{
 "source": "US FDA: original approvals since 2021 (Drugs@FDA)",
 "attribution": "Source: U.S. Food and Drug Administration, Drugs@FDA via openFDA. Not endorsed by the FDA.",
 "licence": "Public domain (U.S. government work); see openFDA terms",
 "retrieved": "2026-10-13T06:04:13+00:00",
 "count": 4765,
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  {
   "application_number": "ANDA215245",
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   "application_number": "ANDA220460",
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  {
   "application_number": "ANDA219997",
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   "application_number": "ANDA218675",
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    "TICAGRELOR"
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    "TICAGRELOR"
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    "TABLET"
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    "ORAL"
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   "application_number": "ANDA219931",
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    "SEVELAMER CARBONATE"
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    "SEVELAMER CARBONATE"
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    "TABLET"
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    "ORAL"
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  },
  {
   "application_number": "ANDA219267",
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   "sponsor_name": "AJENAT PHARMS",
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    "GLYCOPYRROLATE"
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    "GLYCOPYRROLATE"
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    "ORAL"
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  {
   "application_number": "ANDA219265",
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    "LOMUSTINE"
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    "LOMUSTINE"
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    "CAPSULE"
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    "ORAL"
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   "approval_date": "2025-10-27",
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  {
   "application_number": "NDA221021",
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    "CARBON DIOXIDE, USP"
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    "CARBON DIOXIDE"
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    "GAS"
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    "INHALATION"
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   "application_number": "NDA219469",
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    "LYNKUET"
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    "ELINZANETANT"
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    "CAPSULE"
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    "ORAL"
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  {
   "application_number": "NDA219108",
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    "ROCURONIUM BROMIDE"
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  {
   "application_number": "ANDA217345",
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    "ATROPINE SULFATE"
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   "application_number": "NDA220256",
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    "CLONIDINE HYDROCHLORIDE"
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    "DEHYDRATED ALCOHOL"
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    "DALBAVANCIN HYDROCHLORIDE"
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  {
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   "approval_date": "2025-10-03",
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   "approval_date": "2025-10-02",
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  {
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  {
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    "OPHTHALMIC"
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   "submission_class": "Type 3 - New Dosage Form and Type 4 - New Combination"
  },
  {
   "application_number": "ANDA219060",
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   "sponsor_name": "RUBICON RESEARCH",
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    "FLUTICASONE PROPIONATE"
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    "FLUTICASONE PROPIONATE"
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    "NASAL"
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   "application_number": "ANDA218399",
   "application_type": "ANDA",
   "sponsor_name": "ALEMBIC",
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    "TRETINOIN"
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    "CREAM"
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    "TOPICAL"
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   "approval_date": "2025-08-14",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
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   "application_number": "ANDA219864",
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   "approval_date": "2025-08-13",
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  {
   "application_number": "NDA217673",
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   "sponsor_name": "INSMED INC",
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    "BRENSOCATIB"
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   "approval_date": "2025-08-12",
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  },
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   "application_number": "ANDA217358",
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    "DIVALPROEX SODIUM"
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   "application_number": "ANDA219692",
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    "DEFLAZACORT"
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   "approval_date": "2025-07-31",
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   "submission_class": "Type 9 - New indication submitted as distinct BLA, consolidated"
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   "approval_date": "2025-07-30",
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    "FLUVOXAMINE MALEATE"
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   "sponsor_name": "PADAGIS ISRAEL",
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    "TAZAROTENE"
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    "LOTION"
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   "approval_date": "2025-07-29",
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   "application_number": "NDA219666",
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   "sponsor_name": "PTC THERAP",
   "brand_names": [
    "SEPHIENCE"
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    "SEPIAPTERIN"
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   "application_number": "ANDA219939",
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    "CARBAMAZEPINE"
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   "application_number": "ANDA217761",
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    "AVATROMBOPAG MALEATE"
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    "FAMOTIDINE"
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    "CELECOXIB"
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   ],
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    "INJECTABLE"
   ],
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    "INJECTION"
   ],
   "approval_date": "2025-06-23",
   "review_priority": "PRIORITY",
   "submission_class": "Type 1 - New Molecular Entity"
  },
  {
   "application_number": "ANDA219509",
   "application_type": "ANDA",
   "sponsor_name": "TP ANDA HOLDINGS",
   "brand_names": [
    "PREDNISOLONE"
   ],
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    "PREDNISOLONE"
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    "SOLUTION"
   ],
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    "ORAL"
   ],
   "approval_date": "2025-06-23",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA219444",
   "application_type": "ANDA",
   "sponsor_name": "BRECKENRIDGE",
   "brand_names": [
    "DEHYDRATED ALCOHOL"
   ],
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    "DEHYDRATED ALCOHOL"
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    "SOLUTION"
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    "INTRA-ARTERIAL"
   ],
   "approval_date": "2025-06-23",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA219400",
   "application_type": "ANDA",
   "sponsor_name": "XGEN PHARMS",
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    "DEHYDRATED ALCOHOL"
   ],
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    "DEHYDRATED ALCOHOL"
   ],
   "dosage_forms": [
    "SOLUTION"
   ],
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    "INTRA-ARTERIAL"
   ],
   "approval_date": "2025-06-23",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA219242",
   "application_type": "ANDA",
   "sponsor_name": "RISING",
   "brand_names": [
    "DICYCLOMINE HYDROCHLORIDE"
   ],
   "active_ingredients": [
    "DICYCLOMINE HYDROCHLORIDE"
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    "CAPSULE"
   ],
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    "ORAL"
   ],
   "approval_date": "2025-06-23",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA219153",
   "application_type": "ANDA",
   "sponsor_name": "BIONPHARMA",
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    "FAMOTIDINE"
   ],
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    "FAMOTIDINE"
   ],
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    "FOR SUSPENSION"
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    "ORAL"
   ],
   "approval_date": "2025-06-23",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA219084",
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   "sponsor_name": "BROOKS STERISCIENCE",
   "brand_names": [
    "MEROPENEM"
   ],
   "active_ingredients": [
    "MEROPENEM"
   ],
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    "POWDER"
   ],
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    "INTRAVENOUS"
   ],
   "approval_date": "2025-06-23",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA218389",
   "application_type": "ANDA",
   "sponsor_name": "UNIQUE PHARM",
   "brand_names": [
    "AMITRIPTYLINE HYDROCHLORIDE"
   ],
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    "AMITRIPTYLINE HYDROCHLORIDE"
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2025-06-23",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA217845",
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   "sponsor_name": "ACCORD HLTHCARE",
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    "DEHYDRATED ALCOHOL"
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    "DEHYDRATED ALCOHOL"
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    "SOLUTION"
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    "INTRA-ARTERIAL"
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   "approval_date": "2025-06-23",
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  },
  {
   "application_number": "ANDA211834",
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   "sponsor_name": "TORRENT",
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    "APREMILAST"
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    "APREMILAST"
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    "TABLET"
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    "ORAL"
   ],
   "approval_date": "2025-06-20",
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  },
  {
   "application_number": "NDA220020",
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   "sponsor_name": "GILEAD SCIENCES INC",
   "brand_names": [
    "YEZTUGO"
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   "active_ingredients": [
    "LENACAPAVIR SODIUM"
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2025-06-18",
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   "submission_class": "Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated"
  },
  {
   "application_number": "NDA220018",
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    "YEZTUGO"
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    "LENACAPAVIR",
    "LENACAPAVIR SODIUM"
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    "SOLUTION"
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   "routes": [
    "SUBCUTANEOUS"
   ],
   "approval_date": "2025-06-18",
   "review_priority": "PRIORITY",
   "submission_class": "Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated"
  },
  {
   "application_number": "ANDA219775",
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   "brand_names": [
    "ACETAZOLAMIDE SODIUM"
   ],
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    "ACETAZOLAMIDE SODIUM"
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    "INJECTABLE"
   ],
   "routes": [
    "INJECTION"
   ],
   "approval_date": "2025-06-17",
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   "submission_class": ""
  },
  {
   "application_number": "NDA220634",
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   "sponsor_name": "GENERAL DISTRIBUTING COMPANY",
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    "CARBON DIOXIDE, USP"
   ],
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    "CARBON DIOXIDE"
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    "GAS"
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   "approval_date": "2025-06-16",
   "review_priority": "UNKNOWN",
   "submission_class": ""
  },
  {
   "application_number": "NDA219847",
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    "ARYNTA"
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    "LISDEXAMFETAMINE DIMESYLATE"
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    "SOLUTION"
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    "ORAL"
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   "approval_date": "2025-06-16",
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   "submission_class": "Type 3 - New Dosage Form"
  },
  {
   "application_number": "BLA761367",
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   "sponsor_name": "CSL BEHRING LLC",
   "brand_names": [
    "ANDEMBRY"
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   "active_ingredients": [
    "GARADACIMAB-GXII"
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    "INJECTABLE"
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    "SUBCUTANEOUS"
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   "approval_date": "2025-06-16",
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   "submission_class": "Type 1 - New Molecular Entity"
  },
  {
   "application_number": "ANDA217560",
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   "sponsor_name": "HETERO LABS LTD VI",
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    "PLERIXAFOR"
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    "PLERIXAFOR"
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    "SOLUTION"
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    "SUBCUTANEOUS"
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   "approval_date": "2025-06-16",
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  },
  {
   "application_number": "ANDA219612",
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   "sponsor_name": "CARNEGIE",
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    "CLINDAMYCIN PHOSPHATE"
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    "CLINDAMYCIN PHOSPHATE"
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    "SWAB"
   ],
   "routes": [
    "TOPICAL"
   ],
   "approval_date": "2025-06-13",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA215913",
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   "sponsor_name": "ZENARA",
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   ],
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    "SAFINAMIDE MESYLATE"
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    "TABLET"
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    "ORAL"
   ],
   "approval_date": "2025-06-13",
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   "submission_class": ""
  },
  {
   "application_number": "NDA215793",
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   "sponsor_name": "UROGEN PHARMA",
   "brand_names": [
    "ZUSDURI"
   ],
   "active_ingredients": [
    "MITOMYCIN"
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    "POWDER"
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   "routes": [
    "INTRAVESICAL"
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   "approval_date": "2025-06-12",
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   "submission_class": "Type 3 - New Dosage Form"
  },
  {
   "application_number": "ANDA213615",
   "application_type": "ANDA",
   "sponsor_name": "CARDINAL HLTH 414",
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    "SODIUM IODIDE I 131"
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    "SODIUM IODIDE I-131"
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   "dosage_forms": [
    "SOLUTION"
   ],
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    "ORAL"
   ],
   "approval_date": "2025-06-12",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA208175",
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   "sponsor_name": "DR REDDYS LABS SA",
   "brand_names": [
    "PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE"
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    "PHENTERMINE HYDROCHLORIDE",
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   ],
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   "routes": [
    "ORAL"
   ],
   "approval_date": "2025-06-12",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "NDA219713",
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   "brand_names": [
    "IBTROZI"
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   "active_ingredients": [
    "TALETRECTINIB ADIPATE"
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   "approval_date": "2025-06-11",
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  {
   "application_number": "ANDA219633",
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    "SELENIOUS ACID"
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    "SOLUTION"
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    "INTRAVENOUS"
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   "approval_date": "2025-06-11",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA218797",
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    "SAPROPTERIN DIHYDROCHLORIDE"
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    "TABLET"
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    "ORAL"
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   "approval_date": "2025-06-11",
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  },
  {
   "application_number": "ANDA218729",
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    "TRANEXAMIC ACID"
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    "TABLET"
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   ],
   "approval_date": "2025-06-11",
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  {
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    "PREDNISOLONE ACETATE"
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    "SUSPENSION/DROPS"
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    "OPHTHALMIC"
   ],
   "approval_date": "2025-06-11",
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  },
  {
   "application_number": "ANDA211072",
   "application_type": "ANDA",
   "sponsor_name": "UBI",
   "brand_names": [
    "OLANZAPINE"
   ],
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    "OLANZAPINE"
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    "POWDER"
   ],
   "routes": [
    "INTRAMUSCULAR"
   ],
   "approval_date": "2025-06-11",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "NDA218785",
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   "sponsor_name": "BEONE MEDICINES USA",
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   ],
   "active_ingredients": [
    "ZANUBRUTINIB"
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    "CAPSULE",
    "TABLET"
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    "ORAL"
   ],
   "approval_date": "2025-06-10",
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  },
  {
   "application_number": "ANDA217624",
   "application_type": "ANDA",
   "sponsor_name": "STIRA",
   "brand_names": [
    "ZINC SULFATE"
   ],
   "active_ingredients": [
    "ZINC SULFATE"
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    "SOLUTION"
   ],
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    "INTRAVENOUS"
   ],
   "approval_date": "2025-06-10",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA214912",
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   "sponsor_name": "LYNE",
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    "SODIUM POLYSTYRENE SULFONATE"
   ],
   "active_ingredients": [
    "SODIUM POLYSTYRENE SULFONATE"
   ],
   "dosage_forms": [
    "SUSPENSION"
   ],
   "routes": [
    "ORAL, RECTAL"
   ],
   "approval_date": "2025-06-10",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "NDA217472",
   "application_type": "NDA",
   "sponsor_name": "FRESENIUS KABI USA",
   "brand_names": [
    "ROCURONIUM BROMIDE"
   ],
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    "ROCURONIUM BROMIDE"
   ],
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    "SOLUTION"
   ],
   "routes": [
    "INTRAVENOUS"
   ],
   "approval_date": "2025-06-09",
   "review_priority": "STANDARD",
   "submission_class": "Type 5 - New Formulation or New Manufacturer"
  },
  {
   "application_number": "BLA761432",
   "application_type": "BLA",
   "sponsor_name": "MERCK SHARP DOHME",
   "brand_names": [
    "ENFLONSIA"
   ],
   "active_ingredients": [
    "CLESROVIMAB-CFOR"
   ],
   "dosage_forms": [
    "INJECTION"
   ],
   "routes": [
    "SOLUTION"
   ],
   "approval_date": "2025-06-09",
   "review_priority": "PRIORITY",
   "submission_class": "Type 1 - New Molecular Entity"
  },
  {
   "application_number": "ANDA218384",
   "application_type": "ANDA",
   "sponsor_name": "AMNEAL",
   "brand_names": [
    "SCOPOLAMINE"
   ],
   "active_ingredients": [
    "SCOPOLAMINE"
   ],
   "dosage_forms": [
    "SYSTEM"
   ],
   "routes": [
    "TRANSDERMAL"
   ],
   "approval_date": "2025-06-09",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA217437",
   "application_type": "ANDA",
   "sponsor_name": "PH HEALTH",
   "brand_names": [
    "LEUPROLIDE ACETATE"
   ],
   "active_ingredients": [
    "LEUPROLIDE ACETATE"
   ],
   "dosage_forms": [
    "SOLUTION"
   ],
   "routes": [
    "SUBCUTANEOUS"
   ],
   "approval_date": "2025-06-09",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA216797",
   "application_type": "ANDA",
   "sponsor_name": "AUROBINDO PHARMA",
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   ],
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    "SAPROPTERIN DIHYDROCHLORIDE"
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   "dosage_forms": [
    "TABLET"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2025-06-09",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA214310",
   "application_type": "ANDA",
   "sponsor_name": "SANDOZ",
   "brand_names": [
    "ERIBULIN MESYLATE"
   ],
   "active_ingredients": [
    "ERIBULIN MESYLATE"
   ],
   "dosage_forms": [
    "SOLUTION"
   ],
   "routes": [
    "INTRAVENOUS"
   ],
   "approval_date": "2025-06-09",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA218310",
   "application_type": "ANDA",
   "sponsor_name": "PRINSTON INC",
   "brand_names": [
    "DICYCLOMINE HYDROCHLORIDE"
   ],
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    "DICYCLOMINE HYDROCHLORIDE"
   ],
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2025-06-06",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "NDA219423",
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   "brand_names": [
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   ],
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    "AMLODIPINE BESYLATE",
    "INDAPAMIDE",
    "TELMISARTAN"
   ],
   "dosage_forms": [
    "TABLET"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2025-06-05",
   "review_priority": "STANDARD",
   "submission_class": "Type 4 - New Combination"
  },
  {
   "application_number": "NDA218395",
   "application_type": "NDA",
   "sponsor_name": "AZURITY",
   "brand_names": [
    "XIFYRM"
   ],
   "active_ingredients": [
    "MELOXICAM"
   ],
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    "SOLUTION"
   ],
   "routes": [
    "INTRAVENOUS"
   ],
   "approval_date": "2025-06-05",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA218321",
   "application_type": "ANDA",
   "sponsor_name": "RUBICON RESEARCH",
   "brand_names": [
    "FLUTICASONE PROPIONATE"
   ],
   "active_ingredients": [
    "FLUTICASONE PROPIONATE"
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   "dosage_forms": [
    "SPRAY, METERED"
   ],
   "routes": [
    "NASAL"
   ],
   "approval_date": "2025-06-05",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA216460",
   "application_type": "ANDA",
   "sponsor_name": "RUBICON RESEARCH",
   "brand_names": [
    "VALSARTAN"
   ],
   "active_ingredients": [
    "VALSARTAN"
   ],
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    "SOLUTION"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2025-06-05",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA204144",
   "application_type": "ANDA",
   "sponsor_name": "PH HEALTH",
   "brand_names": [
    "SITAGLIPTIN AND METFORMIN HYDROCHLORIDE"
   ],
   "active_ingredients": [
    "METFORMIN HYDROCHLORIDE",
    "SITAGLIPTIN PHOSPHATE"
   ],
   "dosage_forms": [
    "TABLET, EXTENDED RELEASE"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2025-06-04",
   "review_priority": "",
   "submission_class": ""
  },
  {
   "application_number": "ANDA218144",
   "application_type": "ANDA",
   "sponsor_name": "GLAND",
   "brand_names": [
    "EPINEPHRINE"
   ],
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    "EPINEPHRINE"
   ],
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    "SOLUTION"
   ],
   "routes": [
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   "application_number": "ANDA216966",
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    "ANGIOTENSIN ll ACETATE"
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  },
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    "EPINEPHRINE BITARTRATE"
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   "approval_date": "2025-02-14",
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    "GADOTERIDOL"
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    "FORMOTEROL FUMARATE"
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    "SOLUTION"
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    "INHALATION"
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   "application_number": "ANDA218191",
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    "DIFLUPREDNATE"
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    "SUCCINYLCHOLINE CHLORIDE"
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    "SOLUTION"
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    "DORZOLAMIDE HYDROCHLORIDE"
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    "SELENIOUS ACID"
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    "SELENIOUS ACID"
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    "SILODOSIN"
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    "ORAL"
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   "application_number": "NDA217906",
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   "application_number": "ANDA217841",
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    "VENLAFAXINE HYDROCHLORIDE"
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   "application_number": "ANDA219239",
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    "EPINEPHRINE"
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   "application_number": "ANDA218966",
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   "approval_date": "2025-02-02",
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   "submission_class": "Medical Gas"
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   "application_number": "ANDA219163",
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   "approval_date": "2025-01-30",
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   "approval_date": "2025-01-30",
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   "approval_date": "2025-01-29",
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   "approval_date": "2025-01-28",
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   "approval_date": "2025-01-28",
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    "DOXYCYCLINE"
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   "submission_class": ""
  },
  {
   "application_number": "ANDA210390",
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    "DIMETHYL FUMARATE"
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    "DIMETHYL FUMARATE"
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    "CAPSULE, DELAYED RELEASE"
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    "ORAL"
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   "approval_date": "2025-01-06",
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  },
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   "application_number": "ANDA216233",
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    "CLOFARABINE"
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    "CLOFARABINE"
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    "SOLUTION"
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    "INTRAVENOUS"
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   "approval_date": "2025-01-03",
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  },
  {
   "application_number": "ANDA214966",
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    "PHYTONADIONE"
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    "PHYTONADIONE"
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    "INJECTABLE"
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    "INJECTION"
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  },
  {
   "application_number": "ANDA218640",
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    "LUBIPROSTONE"
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    "CAPSULE"
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  },
  {
   "application_number": "ANDA209434",
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    "ORAL"
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   "approval_date": "2025-01-02",
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  },
  {
   "application_number": "ANDA219036",
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    "SUMATRIPTAN SUCCINATE"
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    "TABLET"
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   "approval_date": "2024-12-31",
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  },
  {
   "application_number": "ANDA217178",
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    "DIAZEPAM"
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  },
  {
   "application_number": "ANDA216750",
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    "METRONIDAZOLE"
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    "METRONIDAZOLE"
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    "VAGINAL"
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  },
  {
   "application_number": "ANDA215978",
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    "SAFINAMIDE MESYLATE"
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    "SAFINAMIDE MESYLATE"
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    "TABLET"
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  {
   "application_number": "ANDA214847",
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    "GLYCOPYRROLATE"
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  },
  {
   "application_number": "ANDA213116",
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    "TROMETHAMINE"
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    "TROMETHAMINE"
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    "INJECTION"
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  {
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   "approval_date": "2024-12-30",
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  {
   "application_number": "BLA761429",
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  },
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  },
  {
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  },
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   ],
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  },
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  },
  {
   "application_number": "ANDA218492",
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    "PRUCALOPRIDE SUCCINATE"
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   ],
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  },
  {
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  },
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   "application_number": "ANDA219057",
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    "POSACONAZOLE"
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   "approval_date": "2024-12-23",
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  },
  {
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    "EDARAVONE"
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    "SOLUTION"
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  },
  {
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    "ENTECAVIR"
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  {
   "application_number": "ANDA215503",
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   ],
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  {
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   ],
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    "VANZACAFTOR CALCIUM"
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   "approval_date": "2024-12-20",
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   "approval_date": "2024-12-20",
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  },
  {
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    "ICOSAPENT ETHYL"
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   ],
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   ],
   "approval_date": "2024-12-20",
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  },
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   "sponsor_name": "SOMERSET THERAPS LLC",
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   ],
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    "TETRACAINE HYDROCHLORIDE"
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  },
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   ],
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    "SILDENAFIL CITRATE"
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   ],
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   ],
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   "submission_class": "Not Applicable"
  },
  {
   "application_number": "NDA218614",
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   "brand_names": [
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    "OLEZARSEN SODIUM"
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   ],
   "approval_date": "2024-12-19",
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   "submission_class": "Type 1 - New Molecular Entity"
  },
  {
   "application_number": "ANDA218793",
   "application_type": "ANDA",
   "sponsor_name": "ALEMBIC",
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   ],
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    "DIVALPROEX SODIUM"
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   ],
   "approval_date": "2024-12-19",
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  },
  {
   "application_number": "ANDA218644",
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   "sponsor_name": "EPIC PHARMA LLC",
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   ],
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    "CYCLOPHOSPHAMIDE"
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   ],
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    "INJECTION"
   ],
   "approval_date": "2024-12-19",
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  },
  {
   "application_number": "ANDA215476",
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   "sponsor_name": "LEADING",
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    "CARBINOXAMINE MALEATE"
   ],
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    "CARBINOXAMINE MALEATE"
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   ],
   "approval_date": "2024-12-19",
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  },
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   "application_number": "ANDA212663",
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   "sponsor_name": "MACLEODS PHARMS",
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   "approval_date": "2024-12-19",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA212112",
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   "sponsor_name": "HIKMA PHARMS",
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    "PHYTONADIONE"
   ],
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    "PHYTONADIONE"
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   ],
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   ],
   "approval_date": "2024-12-19",
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  },
  {
   "application_number": "ANDA207922",
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   "sponsor_name": "BRECKENRIDGE",
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   ],
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    "DABIGATRAN ETEXILATE MESYLATE"
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   ],
   "approval_date": "2024-12-19",
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  },
  {
   "application_number": "ANDA203540",
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   "sponsor_name": "HETERO LABS LTD III",
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   ],
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    "RALTEGRAVIR POTASSIUM"
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    "TABLET"
   ],
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   ],
   "approval_date": "2024-12-19",
   "review_priority": "",
   "submission_class": ""
  },
  {
   "application_number": "NDA218171",
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   "sponsor_name": "XCOVERY",
   "brand_names": [
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   ],
   "active_ingredients": [
    "ENSARTINIB HYDROCHLORIDE"
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   ],
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   ],
   "approval_date": "2024-12-18",
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  },
  {
   "application_number": "ANDA218312",
   "application_type": "ANDA",
   "sponsor_name": "BRIGHTGENE",
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   ],
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    "FONDAPARINUX SODIUM"
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   ],
   "approval_date": "2024-12-18",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA218129",
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   "sponsor_name": "GLAND",
   "brand_names": [
    "PHENYLEPHRINE HYDROCHLORIDE"
   ],
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    "PHENYLEPHRINE HYDROCHLORIDE"
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    "SOLUTION/DROPS"
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   ],
   "approval_date": "2024-12-18",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA215006",
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   "sponsor_name": "SOMERSET",
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   ],
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    "OLOPATADINE HYDROCHLORIDE"
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  },
  {
   "application_number": "ANDA212748",
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    "PIRFENIDONE"
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   ],
   "approval_date": "2024-12-18",
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  },
  {
   "application_number": "BLA761338",
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   "brand_names": [
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   ],
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    "USTEKINUMAB-STBA"
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    "INJECTABLE"
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    "INTRAVENOUS"
   ],
   "approval_date": "2024-12-17",
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   "submission_class": "Type 2 - New Active Ingredient"
  },
  {
   "application_number": "ANDA219120",
   "application_type": "ANDA",
   "sponsor_name": "ZYDUS LIFESCIENCES",
   "brand_names": [
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   ],
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    "LIDOCAINE",
    "PRILOCAINE"
   ],
   "dosage_forms": [
    "CREAM"
   ],
   "routes": [
    "TOPICAL"
   ],
   "approval_date": "2024-12-17",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA218850",
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    "LEVOTHYROXINE SODIUM"
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    "INTRAVENOUS"
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   "application_number": "ANDA215005",
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    "ATROPINE SULFATE"
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    "SOLUTION"
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   "application_number": "ANDA212222",
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    "OINTMENT"
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   "application_number": "NDA216017",
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    "IOMERVU"
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    "IOMEPROL"
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    "SOLUTION"
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  {
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    "SOLUTION"
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  },
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    "CALCIUM CHLORIDE"
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    "INJECTION"
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    "LATANOPROST"
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   "approval_date": "2024-11-15",
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   "approval_date": "2024-11-15",
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  {
   "application_number": "ANDA218952",
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    "LISDEXAMFETAMINE DIMESYLATE"
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   "approval_date": "2024-11-13",
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    "NALMEFENE HYDROCHLORIDE"
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    "DENILEUKIN DIFTITOX-CXDL"
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   "approval_date": "2024-07-23",
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    "BROMFENAC SODIUM"
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   "application_number": "ANDA218673",
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   "application_number": "ANDA214597",
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    "ZINC SULFATE"
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   "application_number": "ANDA211943",
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    "CYCLOSPORINE"
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    "CYCLOSPORINE"
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   "application_number": "ANDA217764",
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   "application_number": "ANDA217303",
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   "approval_date": "2024-06-21",
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  {
   "application_number": "ANDA217685",
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    "DOXYCYCLINE HYCLATE"
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   "approval_date": "2024-06-21",
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    "ALVAIZ"
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    "ELTROMBOPAG CHOLINE"
   ],
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    "TABLET"
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    "ORAL"
   ],
   "approval_date": "2023-11-29",
   "review_priority": "STANDARD",
   "submission_class": "Type 2 - New Active Ingredient"
  },
  {
   "application_number": "ANDA217031",
   "application_type": "ANDA",
   "sponsor_name": "BIOCON PHARMA",
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    "MYCOPHENOLATE SODIUM"
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    "MYCOPHENOLATE SODIUM"
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    "TABLET, DELAYED RELEASE"
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    "ORAL"
   ],
   "approval_date": "2023-11-29",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA216667",
   "application_type": "ANDA",
   "sponsor_name": "EUGIA PHARMA",
   "brand_names": [
    "BUDESONIDE"
   ],
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    "BUDESONIDE"
   ],
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    "SUSPENSION"
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    "INHALATION"
   ],
   "approval_date": "2023-11-29",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA213987",
   "application_type": "ANDA",
   "sponsor_name": "SCIECURE",
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    "FOSCARNET SODIUM"
   ],
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    "FOSCARNET SODIUM"
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    "SOLUTION"
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    "INTRAVENOUS"
   ],
   "approval_date": "2023-11-29",
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  },
  {
   "application_number": "ANDA213956",
   "application_type": "ANDA",
   "sponsor_name": "HIKMA PHARMS",
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    "LOTEPREDNOL ETABONATE"
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    "LOTEPREDNOL ETABONATE"
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    "GEL"
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    "OPHTHALMIC"
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  },
  {
   "application_number": "ANDA213442",
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   "sponsor_name": "ZYDUS PHARMS",
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    "IVABRADINE HYDROCHLORIDE"
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    "IVABRADINE HYDROCHLORIDE"
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    "TABLET"
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    "ORAL"
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  },
  {
   "application_number": "ANDA210374",
   "application_type": "ANDA",
   "sponsor_name": "DEVA HOLDING AS",
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    "AMOXICILLIN AND CLAVULANATE POTASSIUM"
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    "AMOXICILLIN",
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    "ORAL"
   ],
   "approval_date": "2023-11-29",
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  },
  {
   "application_number": "ANDA218045",
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    "SILDENAFIL CITRATE"
   ],
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    "SILDENAFIL CITRATE"
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    "TABLET"
   ],
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    "ORAL"
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   "approval_date": "2023-11-28",
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  },
  {
   "application_number": "ANDA215389",
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   "sponsor_name": "MSN",
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    "DARUNAVIR"
   ],
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    "DARUNAVIR"
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    "TABLET"
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    "ORAL"
   ],
   "approval_date": "2023-11-28",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA213782",
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   "sponsor_name": "ALKEM LABS LTD",
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    "BREXPIPRAZOLE"
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    "BREXPIPRAZOLE"
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    "TABLET"
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    "ORAL"
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  {
   "application_number": "ANDA211578",
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    "DARUNAVIR"
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    "DARUNAVIR"
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    "TABLET"
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    "ORAL"
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   "approval_date": "2023-11-28",
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  },
  {
   "application_number": "ANDA210677",
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    "DARUNAVIR"
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    "DARUNAVIR"
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    "TABLET"
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    "ORAL"
   ],
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  },
  {
   "application_number": "ANDA206288",
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    "DARUNAVIR"
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    "DARUNAVIR"
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    "TABLET"
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    "ORAL"
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  },
  {
   "application_number": "NDA217677",
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    "OGSIVEO"
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    "NIROGACESTAT HYDROBROMIDE"
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    "TABLET"
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    "ORAL"
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   "approval_date": "2023-11-27",
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  {
   "application_number": "ANDA213163",
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    "ZAFIRLUKAST"
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    "TABLET"
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    "ORAL"
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  {
   "application_number": "ANDA218009",
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    "OSELTAMIVIR PHOSPHATE"
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    "ORAL"
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   "approval_date": "2023-11-24",
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  },
  {
   "application_number": "ANDA217846",
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    "BRIMONIDINE TARTRATE"
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  },
  {
   "application_number": "ANDA215469",
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  {
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    "PODOFILOX"
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  {
   "application_number": "ANDA206027",
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  {
   "application_number": "ANDA217707",
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    "PROGESTERONE"
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    "INJECTION"
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   "approval_date": "2023-11-21",
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  {
   "application_number": "ANDA212361",
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    "ACYCLOVIR"
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    "CREAM"
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    "TOPICAL"
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   "approval_date": "2023-11-21",
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  {
   "application_number": "ANDA210066",
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   "approval_date": "2023-11-21",
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  {
   "application_number": "ANDA205950",
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    "TRIMETHOBENZAMIDE HYDROCHLORIDE"
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   "approval_date": "2023-11-21",
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  {
   "application_number": "ANDA217792",
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   ],
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   "approval_date": "2023-11-20",
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  },
  {
   "application_number": "ANDA217020",
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   "approval_date": "2023-11-20",
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  {
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    "LEVETIRACETAM"
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   "approval_date": "2023-11-20",
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  {
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    "BREXPIPRAZOLE"
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   "approval_date": "2023-11-20",
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  },
  {
   "application_number": "ANDA208928",
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    "GABAPENTIN"
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   "approval_date": "2023-11-20",
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  {
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    "PITAVASTATIN CALCIUM"
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   ],
   "approval_date": "2023-11-20",
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  {
   "application_number": "ANDA217231",
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    "TOPIRAMATE"
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   ],
   "approval_date": "2023-11-17",
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  {
   "application_number": "ANDA215049",
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    "DIATRIZOATE MEGLUMINE",
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   "dosage_forms": [
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   ],
   "approval_date": "2023-11-17",
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   "submission_class": ""
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  {
   "application_number": "NDA218197",
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   "sponsor_name": "ASTRAZENECA",
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   ],
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    "CAPIVASERTIB"
   ],
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    "TABLET"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2023-11-16",
   "review_priority": "PRIORITY",
   "submission_class": "Type 1 - New Molecular Entity"
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  {
   "application_number": "BLA761134",
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   "sponsor_name": "EVIVE BIOTECHNOLOGY",
   "brand_names": [
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    "EFBEMALENOGRASTIM ALFA-VUXW"
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   ],
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   "approval_date": "2023-11-16",
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  {
   "application_number": "ANDA216075",
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    "GANIRELIX ACETATE"
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   ],
   "approval_date": "2023-11-16",
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  {
   "application_number": "ANDA211097",
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    "TERIPARATIDE"
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   "approval_date": "2023-11-16",
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  },
  {
   "application_number": "ANDA208569",
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    "TERIPARATIDE"
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   "approval_date": "2023-11-16",
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  {
   "application_number": "NDA218213",
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    "REPOTRECTINIB"
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   "routes": [
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   ],
   "approval_date": "2023-11-15",
   "review_priority": "PRIORITY",
   "submission_class": "Type 1 - New Molecular Entity"
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  {
   "application_number": "NDA214520",
   "application_type": "NDA",
   "sponsor_name": "CORMEDIX",
   "brand_names": [
    "DEFENCATH"
   ],
   "active_ingredients": [
    "HEPARIN SODIUM",
    "TAUROLIDINE"
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   "routes": [
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   ],
   "approval_date": "2023-11-15",
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   "submission_class": "Type 1 - New Molecular Entity and Type 4 - New Combination"
  },
  {
   "application_number": "ANDA216007",
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   "sponsor_name": "CHENGDU SHUODE",
   "brand_names": [
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    "NALMEFENE HYDROCHLORIDE"
   ],
   "dosage_forms": [
    "SOLUTION"
   ],
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   ],
   "approval_date": "2023-11-15",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA216524",
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   "sponsor_name": "PADAGIS ISRAEL",
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   ],
   "approval_date": "2023-11-14",
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  },
  {
   "application_number": "ANDA216670",
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    "LACOSAMIDE"
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    "LACOSAMIDE"
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    "SOLUTION"
   ],
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    "INTRAVENOUS"
   ],
   "approval_date": "2023-11-13",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA213516",
   "application_type": "ANDA",
   "sponsor_name": "JUBILANT",
   "brand_names": [
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   ],
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    "TECHNETIUM TC-99M SULFUR COLLOID KIT"
   ],
   "dosage_forms": [
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   ],
   "routes": [
    "INJECTION, ORAL"
   ],
   "approval_date": "2023-11-09",
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   "submission_class": ""
  },
  {
   "application_number": "NDA217806",
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   "sponsor_name": "ELI LILLY AND CO",
   "brand_names": [
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    "ZEPBOUND KWIKPEN",
    "ZEPBOUND (AUTOINJECTOR)"
   ],
   "active_ingredients": [
    "TIRZEPATIDE"
   ],
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    "SOLUTION"
   ],
   "routes": [
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   ],
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   "review_priority": "PRIORITY",
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  },
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    "FRUQUINTINIB"
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   "application_number": "ANDA218290",
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    "BACLOFEN"
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   "application_number": "ANDA216350",
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   "sponsor_name": "RUBICON RESEARCH",
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    "GLIPIZIDE"
   ],
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    "GLIPIZIDE"
   ],
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    "TABLET"
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    "ORAL"
   ],
   "approval_date": "2023-10-03",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA201802",
   "application_type": "ANDA",
   "sponsor_name": "CHARTWELL RX",
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    "EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE"
   ],
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    "EFAVIRENZ",
    "EMTRICITABINE",
    "TENOFOVIR DISOPROXIL FUMARATE"
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-10-03",
   "review_priority": "",
   "submission_class": "Not Applicable"
  },
  {
   "application_number": "ANDA217059",
   "application_type": "ANDA",
   "sponsor_name": "BAXTER HLTHCARE CORP",
   "brand_names": [
    "LEVETIRACETAM IN SODIUM CHLORIDE"
   ],
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    "LEVETIRACETAM"
   ],
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    "INJECTABLE"
   ],
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    "INTRAVENOUS"
   ],
   "approval_date": "2023-10-02",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA216274",
   "application_type": "ANDA",
   "sponsor_name": "AM REGENT",
   "brand_names": [
    "POTASSIUM PHOSPHATES"
   ],
   "active_ingredients": [
    "POTASSIUM PHOSPHATE, DIBASIC",
    "POTASSIUM PHOSPHATE, MONOBASIC"
   ],
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    "SOLUTION"
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    "INTRAVENOUS"
   ],
   "approval_date": "2023-10-02",
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  },
  {
   "application_number": "ANDA213037",
   "application_type": "ANDA",
   "sponsor_name": "SUNSHINE",
   "brand_names": [
    "ARIPIPRAZOLE"
   ],
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    "ARIPIPRAZOLE"
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    "TABLET"
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    "ORAL"
   ],
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  },
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   "application_number": "NDA217569",
   "application_type": "NDA",
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    "VASOPRESSIN"
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    "SOLUTION"
   ],
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   "approval_date": "2023-09-29",
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  },
  {
   "application_number": "NDA216142",
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    "MICAFUNGIN SODIUM"
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    "SOLUTION"
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    "INTRAVENOUS"
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  },
  {
   "application_number": "NDA215842",
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    "RIVFLOZA"
   ],
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    "NEDOSIRAN SODIUM"
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    "SOLUTION"
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    "INJECTION"
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   "approval_date": "2023-09-29",
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  },
  {
   "application_number": "NDA022335",
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   "sponsor_name": "CYCLOMEDICA",
   "brand_names": [
    "TECHNEGAS KIT"
   ],
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    "TECHNETIUM TC-99M LABELED CARBON"
   ],
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    "AEROSOL"
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   "routes": [
    "INHALATION"
   ],
   "approval_date": "2023-09-29",
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  },
  {
   "application_number": "BLA761354",
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    "TOFIDENCE"
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    "TOCILIZUMAB-BAVI"
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    "INJECTION"
   ],
   "approval_date": "2023-09-29",
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  },
  {
   "application_number": "ANDA218015",
   "application_type": "ANDA",
   "sponsor_name": "GRANULES",
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    "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE"
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    "LOSARTAN POTASSIUM"
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   "approval_date": "2023-09-29",
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  },
  {
   "application_number": "ANDA217264",
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   "sponsor_name": "PHARMAZONE",
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    "ESOMEPRAZOLE MAGNESIUM"
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    "ESOMEPRAZOLE MAGNESIUM"
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   ],
   "approval_date": "2023-09-29",
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  },
  {
   "application_number": "NDA215211",
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   ],
   "active_ingredients": [
    "MIGLUSTAT"
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    "ORAL"
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   "approval_date": "2023-09-28",
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  },
  {
   "application_number": "BLA761204",
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   ],
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    "CIPAGLUCOSIDASE ALFA-ATGA"
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    "INJECTION"
   ],
   "approval_date": "2023-09-28",
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  },
  {
   "application_number": "ANDA207293",
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   "approval_date": "2023-09-28",
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  },
  {
   "application_number": "BLA761133",
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    "INJECTION"
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   "approval_date": "2023-09-27",
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  },
  {
   "application_number": "ANDA217134",
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   "sponsor_name": "HAINAN POLY",
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   ],
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    "IOPAMIDOL"
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   ],
   "approval_date": "2023-09-27",
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  },
  {
   "application_number": "ANDA215997",
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   "brand_names": [
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    "DEXTROAMPHETAMINE SULFATE"
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   ],
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   "approval_date": "2023-09-27",
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  {
   "application_number": "ANDA215449",
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    "TOPIRAMATE"
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   ],
   "approval_date": "2023-09-27",
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  {
   "application_number": "ANDA210668",
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   ],
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    "RANOLAZINE"
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   "approval_date": "2023-09-27",
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  {
   "application_number": "NDA217729",
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   "sponsor_name": "PF PRISM CV",
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    "BOSUTINIB MONOHYDRATE"
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   ],
   "approval_date": "2023-09-26",
   "review_priority": "PRIORITY",
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  },
  {
   "application_number": "ANDA216912",
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   "sponsor_name": "SCINOPHARM TAIWAN",
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    "BORTEZOMIB"
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    "INJECTABLE"
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    "INTRAVENOUS, SUBCUTANEOUS"
   ],
   "approval_date": "2023-09-26",
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  },
  {
   "application_number": "ANDA215527",
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   "sponsor_name": "ANNORA PHARMA",
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    "DIVALPROEX SODIUM"
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   ],
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   ],
   "approval_date": "2023-09-26",
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  },
  {
   "application_number": "NDA217064",
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   "sponsor_name": "FAMYGEN LIFE SCI",
   "brand_names": [
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   "active_ingredients": [
    "PHENTOLAMINE MESYLATE"
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    "OPHTHALMIC"
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   "approval_date": "2023-09-25",
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  },
  {
   "application_number": "ANDA218149",
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   ],
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    "TABLET"
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   ],
   "approval_date": "2023-09-25",
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  {
   "application_number": "ANDA216878",
   "application_type": "ANDA",
   "sponsor_name": "HIKMA PHARMS",
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    "TOFACITINIB CITRATE"
   ],
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    "TOFACITINIB CITRATE"
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   ],
   "approval_date": "2023-09-25",
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  {
   "application_number": "ANDA215709",
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   "sponsor_name": "NEXUS",
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    "FLUORESCEIN SODIUM"
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   "approval_date": "2023-09-25",
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  {
   "application_number": "NDA216755",
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   "sponsor_name": "SAPTALIS PHARMS",
   "brand_names": [
    "LIKMEZ"
   ],
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    "METRONIDAZOLE"
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    "ORAL"
   ],
   "approval_date": "2023-09-22",
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  {
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   ],
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   "approval_date": "2023-09-22",
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  },
  {
   "application_number": "ANDA217844",
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   "sponsor_name": "ONESOURCE",
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   ],
   "active_ingredients": [
    "ICOSAPENT ETHYL"
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    "CAPSULE"
   ],
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   ],
   "approval_date": "2023-09-22",
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   "submission_class": ""
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  {
   "application_number": "ANDA212704",
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   "sponsor_name": "AMNEAL PHARMS",
   "brand_names": [
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    "CARBAMAZEPINE"
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    "TABLET, EXTENDED RELEASE"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-09-22",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA216512",
   "application_type": "ANDA",
   "sponsor_name": "MSN",
   "brand_names": [
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   ],
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    "PYRIDOSTIGMINE BROMIDE"
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   "dosage_forms": [
    "SYRUP"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2023-09-21",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA215738",
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   "sponsor_name": "ZHEJIANG POLY PHARM",
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   ],
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    "FLUCONAZOLE"
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   ],
   "approval_date": "2023-09-21",
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   "sponsor_name": "ZYDUS LIFESCIENCES",
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   ],
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    "CLINDAMYCIN PHOSPHATE"
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   "dosage_forms": [
    "GEL"
   ],
   "routes": [
    "TOPICAL"
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   "approval_date": "2023-09-19",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA217529",
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    "FAMOTIDINE"
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   "approval_date": "2023-09-18",
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   "submission_class": ""
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  {
   "application_number": "NDA216873",
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   "sponsor_name": "GLAXOSMITHKLINE",
   "brand_names": [
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   "active_ingredients": [
    "MOMELOTINIB DIHYDROCHLORIDE"
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    "TABLET"
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   ],
   "approval_date": "2023-09-15",
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   "submission_class": "Type 1 - New Molecular Entity"
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  {
   "application_number": "ANDA217575",
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   "sponsor_name": "CAPLIN",
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   ],
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    "NOREPINEPHRINE BITARTRATE"
   ],
   "dosage_forms": [
    "INJECTABLE"
   ],
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    "INJECTION"
   ],
   "approval_date": "2023-09-15",
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  },
  {
   "application_number": "ANDA216969",
   "application_type": "ANDA",
   "sponsor_name": "ALEMBIC",
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    "CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE"
   ],
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    "CHLORDIAZEPOXIDE HYDROCHLORIDE",
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   ],
   "approval_date": "2023-09-15",
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   "submission_class": ""
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  {
   "application_number": "ANDA209992",
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   "sponsor_name": "REGCON HOLDINGS",
   "brand_names": [
    "AMOXICILLIN AND CLAVULANATE POTASSIUM"
   ],
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   "approval_date": "2023-09-15",
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   "submission_class": ""
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   "application_number": "ANDA209991",
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   ],
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    "AMOXICILLIN",
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    "ORAL"
   ],
   "approval_date": "2023-09-15",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA217842",
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   "sponsor_name": "MICRO LABS",
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    "FAMOTIDINE"
   ],
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    "FAMOTIDINE"
   ],
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   ],
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   ],
   "approval_date": "2023-09-14",
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   "submission_class": ""
  },
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   "application_number": "ANDA216419",
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   "sponsor_name": "AUROBINDO PHARMA LTD",
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   ],
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    "CHLORDIAZEPOXIDE HYDROCHLORIDE",
    "CLIDINIUM BROMIDE"
   ],
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   ],
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    "ORAL"
   ],
   "approval_date": "2023-09-14",
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   "submission_class": ""
  },
  {
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   "approval_date": "2023-05-11",
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   "approval_date": "2023-05-09",
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   "application_number": "ANDA217696",
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   "sponsor_name": "NOVITIUM PHARMA",
   "brand_names": [
    "DEXAMETHASONE"
   ],
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    "DEXAMETHASONE"
   ],
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-05-09",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA217197",
   "application_type": "ANDA",
   "sponsor_name": "NE RX PHARMA",
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    "ACETAZOLAMIDE"
   ],
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    "ACETAZOLAMIDE"
   ],
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-05-09",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "NDA211413",
   "application_type": "NDA",
   "sponsor_name": "HQ SPCLT PHARMA",
   "brand_names": [
    "CEFAZOLIN SODIUM"
   ],
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    "CEFAZOLIN SODIUM"
   ],
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    "POWDER"
   ],
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    "INTRAVENOUS"
   ],
   "approval_date": "2023-05-08",
   "review_priority": "STANDARD",
   "submission_class": "Type 5 - New Formulation or New Manufacturer"
  },
  {
   "application_number": "ANDA217195",
   "application_type": "ANDA",
   "sponsor_name": "SENTISS PHARMA",
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    "TIMOLOL MALEATE"
   ],
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    "TIMOLOL MALEATE"
   ],
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    "SOLUTION/DROPS"
   ],
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    "OPHTHALMIC"
   ],
   "approval_date": "2023-05-08",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA215600",
   "application_type": "ANDA",
   "sponsor_name": "AUROBINDO PHARMA",
   "brand_names": [
    "PHENOXYBENZAMINE HYDROCHLORIDE"
   ],
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    "PHENOXYBENZAMINE HYDROCHLORIDE"
   ],
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    "CAPSULE"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-05-08",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA213453",
   "application_type": "ANDA",
   "sponsor_name": "MEITHEAL",
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    "ROCURONIUM BROMIDE"
   ],
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    "ROCURONIUM BROMIDE"
   ],
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    "INJECTABLE"
   ],
   "routes": [
    "INJECTION"
   ],
   "approval_date": "2023-05-08",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "NDA215352",
   "application_type": "NDA",
   "sponsor_name": "EYENOVIA",
   "brand_names": [
    "MYDCOMBI"
   ],
   "active_ingredients": [
    "PHENYLEPHRINE HYDROCHLORIDE",
    "TROPICAMIDE"
   ],
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    "SPRAY, METERED"
   ],
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    "OPHTHALMIC"
   ],
   "approval_date": "2023-05-05",
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   "submission_class": "Type 5 - New Formulation or New Manufacturer"
  },
  {
   "application_number": "NDA216185",
   "application_type": "NDA",
   "sponsor_name": "AUCTA",
   "brand_names": [
    "MOTPOLY XR"
   ],
   "active_ingredients": [
    "LACOSAMIDE"
   ],
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    "CAPSULE, EXTENDED RELEASE"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-05-04",
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   "submission_class": "Type 3 - New Dosage Form"
  },
  {
   "application_number": "ANDA217555",
   "application_type": "ANDA",
   "sponsor_name": "BIONPHARMA",
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    "NICARDIPINE HYDROCHLORIDE"
   ],
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    "NICARDIPINE HYDROCHLORIDE"
   ],
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    "CAPSULE"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-05-03",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA216435",
   "application_type": "ANDA",
   "sponsor_name": "CASPER PHARMA LLC",
   "brand_names": [
    "EDETATE CALCIUM DISODIUM"
   ],
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    "EDETATE CALCIUM DISODIUM"
   ],
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    "INJECTABLE"
   ],
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    "INJECTION"
   ],
   "approval_date": "2023-05-03",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA215705",
   "application_type": "ANDA",
   "sponsor_name": "ZYDUS LIFESCIENCES",
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    "SUCRALFATE"
   ],
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    "SUCRALFATE"
   ],
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-05-03",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA215403",
   "application_type": "ANDA",
   "sponsor_name": "INFORLIFE",
   "brand_names": [
    "ACETAMINOPHEN"
   ],
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    "ACETAMINOPHEN"
   ],
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    "SOLUTION"
   ],
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    "INTRAVENOUS"
   ],
   "approval_date": "2023-05-03",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA212420",
   "application_type": "ANDA",
   "sponsor_name": "UPSHER SMITH LABS",
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    "ELIGLUSTAT TARTRATE"
   ],
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    "ELIGLUSTAT TARTRATE"
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    "CAPSULE"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-05-02",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA209145",
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   "sponsor_name": "SUN PHARM",
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    "ERTAPENEM SODIUM"
   ],
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    "ERTAPENEM SODIUM"
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    "INJECTABLE"
   ],
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    "INTRAMUSCULAR, INTRAVENOUS"
   ],
   "approval_date": "2023-05-02",
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   "submission_class": ""
  },
  {
   "application_number": "NDA214755",
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   "sponsor_name": "ALKERMES INC",
   "brand_names": [
    "LUMRYZ"
   ],
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    "SODIUM OXYBATE"
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    "FOR SUSPENSION, EXTENDED RELEASE"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-05-01",
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  },
  {
   "application_number": "ANDA217260",
   "application_type": "ANDA",
   "sponsor_name": "INGENUS PHARMS LLC",
   "brand_names": [
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   ],
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    "DORZOLAMIDE HYDROCHLORIDE",
    "TIMOLOL MALEATE"
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    "SOLUTION/DROPS"
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    "OPHTHALMIC"
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   "approval_date": "2023-05-01",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA217213",
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   "sponsor_name": "NOVITIUM PHARMA",
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    "METHSUXIMIDE"
   ],
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    "METHSUXIMIDE"
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    "CAPSULE"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-05-01",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA216379",
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   "sponsor_name": "EUGIA PHARMA",
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    "TIROFIBAN HYDROCHLORIDE"
   ],
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    "TIROFIBAN HYDROCHLORIDE"
   ],
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    "SOLUTION"
   ],
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    "INTRAVENOUS"
   ],
   "approval_date": "2023-05-01",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA215376",
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   "sponsor_name": "RUBICON RESEARCH",
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    "AMITRIPTYLINE HYDROCHLORIDE"
   ],
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    "AMITRIPTYLINE HYDROCHLORIDE"
   ],
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-05-01",
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   "submission_class": ""
  },
  {
   "application_number": "NDA216579",
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    "SYMBICORT AEROSPHERE"
   ],
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    "BUDESONIDE",
    "FORMOTEROL FUMARATE"
   ],
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    "AEROSOL, METERED"
   ],
   "routes": [
    "INHALATION"
   ],
   "approval_date": "2023-04-28",
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   "submission_class": "Efficacy"
  },
  {
   "application_number": "NDA214952",
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   "sponsor_name": "CMP DEV LLC",
   "brand_names": [
    "LIQREV"
   ],
   "active_ingredients": [
    "SILDENAFIL CITRATE"
   ],
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    "SUSPENSION"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2023-04-28",
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  },
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   "application_number": "NDA213586",
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   "brand_names": [
    "UZEDY"
   ],
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    "RISPERIDONE"
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    "SUSPENSION, EXTENDED RELEASE"
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   "routes": [
    "SUBCUTANEOUS"
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   "approval_date": "2023-04-28",
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  },
  {
   "application_number": "ANDA216656",
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   "sponsor_name": "XIROMED",
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   ],
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    "ESTRADIOL VALERATE"
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    "INJECTABLE"
   ],
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    "INJECTION"
   ],
   "approval_date": "2023-04-28",
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   "submission_class": ""
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  {
   "application_number": "ANDA215519",
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    "VIGABATRIN"
   ],
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    "VIGABATRIN"
   ],
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-04-28",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA213201",
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   "sponsor_name": "AUROBINDO PHARMA LTD",
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   ],
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    "OMEPRAZOLE MAGNESIUM"
   ],
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    "CAPSULE, DELAYED RELEASE"
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    "ORAL"
   ],
   "approval_date": "2023-04-28",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA204104",
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   "sponsor_name": "PHARMOBEDIENT",
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    "BENDAMUSTINE HYDROCHLORIDE"
   ],
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    "BENDAMUSTINE HYDROCHLORIDE"
   ],
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    "POWDER"
   ],
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    "INTRAVENOUS"
   ],
   "approval_date": "2023-04-28",
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   "submission_class": ""
  },
  {
   "application_number": "NDA217006",
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   "brand_names": [
    "ABILIFY ASIMTUFII"
   ],
   "active_ingredients": [
    "ARIPIPRAZOLE"
   ],
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    "SUSPENSION, EXTENDED RELEASE"
   ],
   "routes": [
    "INTRAMUSCULAR"
   ],
   "approval_date": "2023-04-27",
   "review_priority": "STANDARD",
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  },
  {
   "application_number": "ANDA217293",
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   "sponsor_name": "AJANTA PHARMA LTD",
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    "GUANFACINE HYDROCHLORIDE"
   ],
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    "GUANFACINE HYDROCHLORIDE"
   ],
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-04-27",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA214365",
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   "sponsor_name": "PHARMAZONE",
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   ],
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    "CHLORZOXAZONE"
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    "TABLET"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2023-04-27",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA213267",
   "application_type": "ANDA",
   "sponsor_name": "NATCO",
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    "THALIDOMIDE"
   ],
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    "THALIDOMIDE"
   ],
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    "CAPSULE"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2023-04-27",
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   "submission_class": ""
  },
  {
   "application_number": "NDA217660",
   "application_type": "NDA",
   "sponsor_name": "VERTEX PHARMS INC",
   "brand_names": [
    "TRIKAFTA (COPACKAGED)"
   ],
   "active_ingredients": [
    "ELEXACAFTOR, IVACAFTOR, TEZACAFTOR",
    "IVACAFTOR"
   ],
   "dosage_forms": [
    "GRANULE"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2023-04-26",
   "review_priority": "PRIORITY",
   "submission_class": "Type 3 - New Dosage Form"
  },
  {
   "application_number": "NDA214876",
   "application_type": "NDA",
   "sponsor_name": "GLAXOSMITHKLINE",
   "brand_names": [
    "ZEJULA"
   ],
   "active_ingredients": [
    "NIRAPARIB TOSYLATE"
   ],
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    "TABLET"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2023-04-26",
   "review_priority": "STANDARD",
   "submission_class": "Type 3 - New Dosage Form"
  },
  {
   "application_number": "ANDA217538",
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   ],
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    "DEXAMETHASONE"
   ],
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-04-26",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA216300",
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   "sponsor_name": "BIONPHARMA",
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    "THEOPHYLLINE"
   ],
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    "THEOPHYLLINE"
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   "dosage_forms": [
    "TABLET, EXTENDED RELEASE"
   ],
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    "ORAL"
   ],
   "approval_date": "2023-04-26",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA215755",
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   "sponsor_name": "STRIDES PHARMA",
   "brand_names": [
    "PREGABALIN"
   ],
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    "PREGABALIN"
   ],
   "dosage_forms": [
    "CAPSULE"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2023-04-26",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA211703",
   "application_type": "ANDA",
   "sponsor_name": "HIKMA PHARMS",
   "brand_names": [
    "ISOPROTERENOL HYDROCHLORIDE"
   ],
   "active_ingredients": [
    "ISOPROTERENOL HYDROCHLORIDE"
   ],
   "dosage_forms": [
    "INJECTABLE"
   ],
   "routes": [
    "INJECTION"
   ],
   "approval_date": "2023-04-26",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA208913",
   "application_type": "ANDA",
   "sponsor_name": "ACTAVIS LABS FL INC",
   "brand_names": [
    "GEFITINIB"
   ],
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    "GEFITINIB"
   ],
   "dosage_forms": [
    "TABLET"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2023-04-26",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "NDA215887",
   "application_type": "NDA",
   "sponsor_name": "BIOGEN MA",
   "brand_names": [
    "QALSODY"
   ],
   "active_ingredients": [
    "TOFERSEN"
   ],
   "dosage_forms": [
    "SOLUTION"
   ],
   "routes": [
    "INTRATHECAL"
   ],
   "approval_date": "2023-04-25",
   "review_priority": "PRIORITY",
   "submission_class": "Type 1 - New Molecular Entity"
  },
  {
   "application_number": "ANDA213079",
   "application_type": "ANDA",
   "sponsor_name": "PADAGIS ISRAEL",
   "brand_names": [
    "TAZAROTENE"
   ],
   "active_ingredients": [
    "TAZAROTENE"
   ],
   "dosage_forms": [
    "GEL"
   ],
   "routes": [
    "TOPICAL"
   ],
   "approval_date": "2023-04-25",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA217375",
   "application_type": "ANDA",
   "sponsor_name": "ALKEM LABS LTD",
   "brand_names": [
    "FAMOTIDINE"
   ],
   "active_ingredients": [
    "FAMOTIDINE"
   ],
   "dosage_forms": [
    "TABLET"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2023-04-24",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "NDA215875",
   "application_type": "NDA",
   "sponsor_name": "PH HEALTH",
   "brand_names": [
    "ADRENALIN"
   ],
   "active_ingredients": [
    "EPINEPHRINE"
   ],
   "dosage_forms": [
    "SOLUTION"
   ],
   "routes": [
    "INTRAVENOUS"
   ],
   "approval_date": "2023-04-21",
   "review_priority": "STANDARD",
   "submission_class": "Type 5 - New Formulation or New Manufacturer"
  },
  {
   "application_number": "ANDA217128",
   "application_type": "ANDA",
   "sponsor_name": "ZYDUS LIFESCIENCES",
   "brand_names": [
    "METRONIDAZOLE"
   ],
   "active_ingredients": [
    "METRONIDAZOLE"
   ],
   "dosage_forms": [
    "CREAM"
   ],
   "routes": [
    "TOPICAL"
   ],
   "approval_date": "2023-04-21",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA208567",
   "application_type": "ANDA",
   "sponsor_name": "ALKEM LABS LTD",
   "brand_names": [
    "TICAGRELOR"
   ],
   "active_ingredients": [
    "TICAGRELOR"
   ],
   "dosage_forms": [
    "TABLET"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2023-04-21",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA217656",
   "application_type": "ANDA",
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    "BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE"
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    "BISMUTH SUBCITRATE POTASSIUM",
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    "TETRACYCLINE HYDROCHLORIDE"
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   ],
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    "ORAL"
   ],
   "approval_date": "2023-03-06",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA217295",
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   "sponsor_name": "ALEMBIC",
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    "FLUOROURACIL"
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    "FLUOROURACIL"
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    "INJECTABLE"
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    "INJECTION"
   ],
   "approval_date": "2023-03-03",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA215949",
   "application_type": "ANDA",
   "sponsor_name": "NOVITIUM PHARMA",
   "brand_names": [
    "TADALAFIL"
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    "TADALAFIL"
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    "TABLET"
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    "ORAL"
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  },
  {
   "application_number": "ANDA215368",
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   "sponsor_name": "PHARMOBEDIENT",
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    "CARMUSTINE"
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    "CARMUSTINE"
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    "INJECTABLE"
   ],
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    "INJECTION"
   ],
   "approval_date": "2023-03-03",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA214809",
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   "sponsor_name": "SHORLA",
   "brand_names": [
    "NELARABINE"
   ],
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    "NELARABINE"
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    "INJECTABLE"
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  {
   "application_number": "ANDA217319",
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   "sponsor_name": "CHARTWELL RX",
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    "SEVELAMER CARBONATE"
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    "SEVELAMER CARBONATE"
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   "approval_date": "2023-03-02",
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  },
  {
   "application_number": "ANDA216235",
   "application_type": "ANDA",
   "sponsor_name": "SCIECURE PHARMA INC",
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    "CARBAMAZEPINE"
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    "CARBAMAZEPINE"
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  },
  {
   "application_number": "ANDA216234",
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   "sponsor_name": "CAPLIN",
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    "ROCURONIUM BROMIDE"
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    "ROCURONIUM BROMIDE"
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    "INJECTION"
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  {
   "application_number": "ANDA214671",
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   "sponsor_name": "ZYDUS LIFESCIENCES",
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    "VIGABATRIN"
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    "VIGABATRIN"
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    "ORAL"
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  {
   "application_number": "ANDA211337",
   "application_type": "ANDA",
   "sponsor_name": "REYOUNG",
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    "TENOFOVIR DISOPROXIL FUMARATE"
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    "TENOFOVIR DISOPROXIL FUMARATE"
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    "ORAL"
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  },
  {
   "application_number": "ANDA204836",
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   "sponsor_name": "HETERO LABS LTD V",
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    "MOXIFLOXACIN HYDROCHLORIDE"
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    "MOXIFLOXACIN HYDROCHLORIDE"
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    "ORAL"
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  {
   "application_number": "NDA209471",
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   "sponsor_name": "AFT PHARMS US",
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    "COMBOGESIC"
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    "ACETAMINOPHEN",
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   "approval_date": "2023-03-01",
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  {
   "application_number": "ANDA217377",
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   "sponsor_name": "TWI PHARMS",
   "brand_names": [
    "DILTIAZEM HYDROCHLORIDE"
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    "DILTIAZEM HYDROCHLORIDE"
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  {
   "application_number": "ANDA205976",
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    "TOPIRAMATE"
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    "TOPIRAMATE"
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   "application_number": "NDA216718",
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    "SKYCLARYS"
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    "OMAVELOXOLONE"
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   "application_number": "ANDA215744",
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    "DOCETAXEL"
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   "application_number": "ANDA215658",
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    "GANIRELIX ACETATE"
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   "application_number": "ANDA209968",
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    "PHENYLEPHRINE HYDROCHLORIDE"
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   "application_number": "ANDA206770",
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    "ACYCLOVIR"
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    "GLYCOPYRROLATE"
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   "application_number": "ANDA215876",
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    "MEXILETINE HYDROCHLORIDE"
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    "IOPAMIDOL"
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    "TIOPRONIN"
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   "approval_date": "2023-02-24",
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   "approval_date": "2023-02-24",
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   "approval_date": "2023-02-24",
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    "NEOSTIGMINE METHYLSULFATE"
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   "approval_date": "2023-02-23",
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    "KETOROLAC TROMETHAMINE"
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   "approval_date": "2023-02-23",
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   "application_number": "ANDA215959",
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    "LOSARTAN POTASSIUM"
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   "approval_date": "2023-02-23",
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    "KETOROLAC TROMETHAMINE"
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   "approval_date": "2023-02-23",
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    "BACLOFEN"
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   "approval_date": "2023-02-22",
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    "PITAVASTATIN CALCIUM"
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   "approval_date": "2023-02-22",
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   "submission_class": ""
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    "PROPAFENONE HYDROCHLORIDE"
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   "approval_date": "2023-02-21",
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    "PEGCETACOPLAN"
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   "approval_date": "2023-02-17",
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    "SPARSENTAN"
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   "approval_date": "2023-02-17",
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   "submission_class": "Type 1 - New Molecular Entity"
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   "sponsor_name": "TEVA",
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   "approval_date": "2023-02-17",
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  {
   "application_number": "ANDA216542",
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   "sponsor_name": "SAGENT PHARMS INC",
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    "NEOSTIGMINE METHYLSULFATE"
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   "application_number": "ANDA215408",
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    "DOXEPIN HYDROCHLORIDE"
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   "approval_date": "2023-02-17",
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    "LENALIDOMIDE"
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   "approval_date": "2023-02-17",
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   "approval_date": "2023-02-16",
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   "submission_class": "Type 1 - New Molecular Entity"
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   "application_number": "ANDA216597",
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   "sponsor_name": "AMNEAL",
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    "MAGNESIUM SULFATE"
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   "approval_date": "2023-02-15",
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   "submission_class": ""
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   "application_number": "ANDA215538",
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    "OSELTAMIVIR PHOSPHATE"
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   "approval_date": "2023-02-14",
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   "application_number": "ANDA205447",
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   "brand_names": [
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    "MEDROXYPROGESTERONE ACETATE"
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    "FENTANYL CITRATE"
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    "CLIDINIUM BROMIDE"
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    "ORAL"
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   "submission_class": ""
  },
  {
   "application_number": "ANDA215042",
   "application_type": "ANDA",
   "sponsor_name": "NOVITIUM PHARMA",
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    "PHENOXYBENZAMINE HYDROCHLORIDE"
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    "PHENOXYBENZAMINE HYDROCHLORIDE"
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    "PIRFENIDONE"
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    "ORAL"
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   "application_number": "ANDA212722",
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    "TABLET"
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    "ORAL"
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   "application_number": "ANDA216197",
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    "PREGABALIN"
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    "ORAL"
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  },
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   "application_number": "ANDA214475",
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    "ORAL"
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    "ZONISAMIDE"
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   "application_number": "ANDA215772",
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   "approval_date": "2022-07-08",
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   "approval_date": "2022-07-06",
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    "VENLAFAXINE BESYLATE"
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    "POTASSIUM CHLORIDE",
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    "SODIUM GLUCONATE"
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    "ENALAPRIL MALEATE"
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   "application_number": "ANDA214269",
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   "approval_date": "2022-04-28",
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   "approval_date": "2022-04-27",
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   "approval_date": "2022-04-26",
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   "submission_class": ""
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  {
   "application_number": "NDA215888",
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   "approval_date": "2022-04-26",
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   "submission_class": "Type 1 - New Molecular Entity"
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   "approval_date": "2022-04-22",
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   "submission_class": ""
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   "application_number": "ANDA214596",
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   "approval_date": "2022-04-22",
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   "approval_date": "2022-04-22",
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    "ENZALUTAMIDE"
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    "GLYCOPYRROLATE"
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   "approval_date": "2022-04-21",
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    "DOXYCYCLINE HYCLATE"
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   "application_number": "ANDA216232",
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   "approval_date": "2022-03-17",
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   "submission_class": "Type 8 - Partial Rx to OTC Switch"
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   "approval_date": "2022-03-17",
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    "SUCRALFATE"
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   "approval_date": "2022-02-24",
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   "approval_date": "2022-02-23",
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    "PIRFENIDONE"
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    "CAPSULE"
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    "ORAL"
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   "approval_date": "2022-01-20",
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  {
   "application_number": "ANDA215707",
   "application_type": "ANDA",
   "sponsor_name": "ZYDUS LIFESCIENCES",
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    "VIGABATRIN"
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    "VIGABATRIN"
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    "TABLET"
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    "ORAL"
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  },
  {
   "application_number": "ANDA215038",
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    "OFLOXACIN"
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    "OFLOXACIN"
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    "SOLUTION/DROPS"
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    "OTIC"
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  },
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   "application_number": "ANDA214035",
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    "RANOLAZINE"
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    "TABLET, EXTENDED RELEASE"
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    "ORAL"
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  {
   "application_number": "ANDA213543",
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   "sponsor_name": "LONG GROVE PHARMS",
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    "TRIAMCINOLONE ACETONIDE"
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    "TRIAMCINOLONE ACETONIDE"
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    "INJECTABLE"
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    "INJECTION"
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   "approval_date": "2022-01-19",
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  },
  {
   "application_number": "ANDA215607",
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   "sponsor_name": "ENCUBE",
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    "CLINDAMYCIN PHOSPHATE"
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    "CLINDAMYCIN PHOSPHATE"
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    "LOTION"
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    "TOPICAL"
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  },
  {
   "application_number": "ANDA209920",
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    "LUBIPROSTONE"
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    "LUBIPROSTONE"
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    "CAPSULE"
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    "ORAL"
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   "application_number": "NDA214581",
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    "HYDROXYCHLOROQUINE SULFATE"
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    "TABLET"
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    "ORAL"
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  {
   "application_number": "NDA213871",
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    "CIBINQO"
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    "ABROCITINIB"
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    "TABLET"
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    "ORAL"
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  {
   "application_number": "ANDA215940",
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    "ADAPALENE"
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    "ADAPALENE"
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    "GEL"
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    "TOPICAL"
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  {
   "application_number": "NDA211746",
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    "RYALTRIS"
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    "MOMETASONE FUROATE",
    "OLOPATADINE HYDROCHLORIDE"
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    "NASAL"
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  {
   "application_number": "ANDA214656",
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    "POTASSIUM CHLORIDE"
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    "POTASSIUM CHLORIDE"
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    "SOLUTION"
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    "ORAL"
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  {
   "application_number": "ANDA211894",
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    "OSELTAMIVIR PHOSPHATE"
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   "approval_date": "2022-01-13",
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  {
   "application_number": "ANDA207270",
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    "MORPHINE SULFATE"
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    "TABLET"
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    "ORAL"
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  {
   "application_number": "ANDA215939",
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    "OXCARBAZEPINE"
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    "SCOPOLAMINE"
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    "SYSTEM"
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    "FAMOTIDINE"
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    "ABIRATERONE ACETATE"
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    "PROGESTERONE"
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   "application_number": "ANDA213594",
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   "application_number": "ANDA214105",
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    "METOPROLOL SUCCINATE"
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    "SILODOSIN"
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   "application_number": "ANDA207477",
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   "approval_date": "2022-01-04",
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   "application_number": "ANDA213230",
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    "SILODOSIN"
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   "approval_date": "2022-01-03",
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   "application_number": "ANDA213075",
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    "DOXYCYCLINE HYCLATE"
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   "approval_date": "2022-01-03",
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    "PIRFENIDONE"
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   "approval_date": "2022-01-03",
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   "application_number": "NDA214133",
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   "sponsor_name": "STRONGBRIDGE",
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   "active_ingredients": [
    "LEVOKETOCONAZOLE"
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    "TABLET"
   ],
   "routes": [
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   ],
   "approval_date": "2021-12-30",
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   "submission_class": "Type 2 - New Active Ingredient"
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   "application_number": "ANDA214928",
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    "HYDROCODONE BITARTRATE"
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    "TABLET"
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   "approval_date": "2021-12-30",
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  {
   "application_number": "ANDA214051",
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    "IVABRADINE HYDROCHLORIDE"
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   "approval_date": "2021-12-30",
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  {
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    "HYDROCODONE BITARTRATE"
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   "approval_date": "2021-12-30",
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   "submission_class": "Not Applicable"
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  {
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    "CABAZITAXEL"
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   "approval_date": "2021-12-29",
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   "approval_date": "2021-12-28",
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  {
   "application_number": "ANDA214531",
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    "ALBUTEROL SULFATE"
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   "dosage_forms": [
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   ],
   "routes": [
    "INHALATION"
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   "approval_date": "2021-12-28",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "BLA761180",
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   "sponsor_name": "LEO PHARMA AS",
   "brand_names": [
    "ADBRY"
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   "active_ingredients": [
    "TRALOKINUMAB"
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    "INJECTABLE"
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    "INJECTION"
   ],
   "approval_date": "2021-12-27",
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  {
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    "SIROLIMUS"
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    "SOLUTION"
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   "approval_date": "2021-12-27",
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  {
   "application_number": "ANDA212474",
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   "sponsor_name": "TEVA PHARMS USA INC",
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    "ELIGLUSTAT TARTRATE"
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   ],
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   "approval_date": "2021-12-27",
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   "application_number": "NDA214962",
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   "brand_names": [
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    "FINGOLIMOD LAURYL SULFATE"
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   "dosage_forms": [
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   "approval_date": "2021-12-23",
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   "application_number": "ANDA214608",
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   "sponsor_name": "GRANULES",
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    "PRAZOSIN HYDROCHLORIDE"
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    "CAPSULE"
   ],
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   "approval_date": "2021-12-23",
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   "application_number": "ANDA201513",
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   "sponsor_name": "LUPIN",
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    "SEVELAMER CARBONATE"
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   "dosage_forms": [
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    "ORAL"
   ],
   "approval_date": "2021-12-23",
   "review_priority": "",
   "submission_class": "Not Applicable"
  },
  {
   "application_number": "NDA214012",
   "application_type": "NDA",
   "sponsor_name": "NOVARTIS",
   "brand_names": [
    "LEQVIO"
   ],
   "active_ingredients": [
    "INCLISIRAN SODIUM"
   ],
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    "SOLUTION"
   ],
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    "SUBCUTANEOUS"
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   "approval_date": "2021-12-22",
   "review_priority": "STANDARD",
   "submission_class": "Type 1 - New Molecular Entity"
  },
  {
   "application_number": "ANDA213541",
   "application_type": "ANDA",
   "sponsor_name": "LAURUS",
   "brand_names": [
    "EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE"
   ],
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    "EFAVIRENZ",
    "EMTRICITABINE",
    "TENOFOVIR DISOPROXIL FUMARATE"
   ],
   "dosage_forms": [
    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2021-12-22",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA208120",
   "application_type": "ANDA",
   "sponsor_name": "PHARMOBEDIENT",
   "brand_names": [
    "VALPROATE SODIUM"
   ],
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    "VALPROATE SODIUM"
   ],
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    "INJECTABLE"
   ],
   "routes": [
    "INJECTION"
   ],
   "approval_date": "2021-12-22",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA210285",
   "application_type": "ANDA",
   "sponsor_name": "SAWAI USA",
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    "DIMETHYL FUMARATE"
   ],
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    "DIMETHYL FUMARATE"
   ],
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    "CAPSULE, DELAYED RELEASE"
   ],
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    "ORAL"
   ],
   "approval_date": "2021-12-21",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA205431",
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   "sponsor_name": "TRIS PHARMA INC",
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    "CYPROHEPTADINE HYDROCHLORIDE"
   ],
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    "CYPROHEPTADINE HYDROCHLORIDE"
   ],
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    "SYRUP"
   ],
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    "ORAL"
   ],
   "approval_date": "2021-12-21",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "NDA215859",
   "application_type": "NDA",
   "sponsor_name": "JANSSEN PHARMS",
   "brand_names": [
    "XARELTO"
   ],
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    "RIVAROXABAN"
   ],
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    "FOR SUSPENSION"
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    "ORAL"
   ],
   "approval_date": "2021-12-20",
   "review_priority": "PRIORITY",
   "submission_class": "Type 3 - New Dosage Form"
  },
  {
   "application_number": "NDA215499",
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    "APRETUDE"
   ],
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    "CABOTEGRAVIR"
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    "SUSPENSION, EXTENDED RELEASE"
   ],
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    "INTRAMUSCULAR"
   ],
   "approval_date": "2021-12-20",
   "review_priority": "PRIORITY",
   "submission_class": "Type 5 - New Formulation or New Manufacturer"
  },
  {
   "application_number": "NDA216157",
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   "sponsor_name": "GLOBAL BLOOD THERAPS",
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    "OXBRYTA"
   ],
   "active_ingredients": [
    "VOXELOTOR"
   ],
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    "TABLET, FOR SUSPENSION",
    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2021-12-17",
   "review_priority": "PRIORITY",
   "submission_class": "Type 3 - New Dosage Form"
  },
  {
   "application_number": "NDA215395",
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   "sponsor_name": "INVAGEN PHARMS",
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    "LANREOTIDE ACETATE"
   ],
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    "LANREOTIDE ACETATE"
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    "SOLUTION"
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    "SUBCUTANEOUS"
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   "approval_date": "2021-12-17",
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  },
  {
   "application_number": "NDA214032",
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   "sponsor_name": "TELIX",
   "brand_names": [
    "ILLUCCIX"
   ],
   "active_ingredients": [
    "GALLIUM GA-68 GOZETOTIDE"
   ],
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    "POWDER"
   ],
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    "INTRAVENOUS"
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   "approval_date": "2021-12-17",
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  },
  {
   "application_number": "BLA761224",
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   "sponsor_name": "ASTRAZENECA AB",
   "brand_names": [
    "TEZSPIRE"
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   "active_ingredients": [
    "TEZEPELUMAB-EKKO"
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    "SOLUTION"
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    "SUBCUTANEOUS"
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   "approval_date": "2021-12-17",
   "review_priority": "PRIORITY",
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  },
  {
   "application_number": "BLA761216",
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   "sponsor_name": "EMERGE BIOSCIENCE PTE LTD",
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    "YUSIMRY"
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    "ADALIMUMAB-AQVH"
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    "INJECTABLE"
   ],
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    "INJECTION"
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   "approval_date": "2021-12-17",
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  },
  {
   "application_number": "BLA761215",
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   "sponsor_name": "ELI LILLY CO",
   "brand_names": [
    "REZVOGLAR"
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    "INSULIN GLARGINE-AGLR"
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    "INJECTABLE"
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    "INJECTION"
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   "approval_date": "2021-12-17",
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  {
   "application_number": "BLA761195",
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    "EFGARTIGIMOD ALFA"
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  {
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    "RIFABUTIN"
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   "application_number": "ANDA212917",
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    "NEBIVOLOL HYDROCHLORIDE"
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    "ORAL"
   ],
   "approval_date": "2021-12-17",
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  },
  {
   "application_number": "ANDA211053",
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  },
  {
   "application_number": "ANDA208717",
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   "application_number": "NDA215019",
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    "TABLET, ORALLY DISINTEGRATING"
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    "ORAL"
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   "approval_date": "2021-12-16",
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  {
   "application_number": "NDA215935",
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    "BUDESONIDE"
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    "ORAL"
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   "approval_date": "2021-12-15",
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  },
  {
   "application_number": "ANDA211538",
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   ],
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    "VASOPRESSIN"
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    "SOLUTION"
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    "INTRAVENOUS"
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   "approval_date": "2021-12-15",
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  {
   "application_number": "ANDA212514",
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   "sponsor_name": "SPIL",
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    "AMPHOTERICIN B"
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    "INJECTABLE, LIPOSOMAL"
   ],
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    "INJECTION"
   ],
   "approval_date": "2021-12-14",
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  },
  {
   "application_number": "ANDA213948",
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   ],
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    "FLUTICASONE PROPIONATE",
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    "POWDER"
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   "routes": [
    "INHALATION"
   ],
   "approval_date": "2021-12-13",
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  },
  {
   "application_number": "ANDA213356",
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    "METFORMIN HYDROCHLORIDE"
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   "approval_date": "2021-12-13",
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   "application_number": "ANDA212592",
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    "TIMOLOL MALEATE"
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    "SOLUTION/DROPS"
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   "approval_date": "2021-12-09",
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  {
   "application_number": "ANDA207577",
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   "brand_names": [
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   ],
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    "ETHINYL ESTRADIOL",
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   ],
   "dosage_forms": [
    "RING"
   ],
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   "approval_date": "2021-12-09",
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  },
  {
   "application_number": "ANDA215523",
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   ],
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    "DEXMETHYLPHENIDATE HYDROCHLORIDE"
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    "CAPSULE, EXTENDED RELEASE"
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   "approval_date": "2021-12-08",
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  },
  {
   "application_number": "ANDA213949",
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   ],
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    "LAMOTRIGINE"
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   "approval_date": "2021-12-08",
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  {
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    "THIOTEPA"
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    "INJECTABLE"
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    "INJECTION"
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   "approval_date": "2021-12-08",
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    "CLINDAMYCIN PHOSPHATE"
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   "approval_date": "2021-12-07",
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  },
  {
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    "FEBUXOSTAT"
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    "TABLET"
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   "approval_date": "2021-12-07",
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  },
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   "application_number": "ANDA201275",
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   ],
   "active_ingredients": [
    "SUNITINIB MALATE"
   ],
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    "CAPSULE"
   ],
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    "ORAL"
   ],
   "approval_date": "2021-12-06",
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   "submission_class": "Not Applicable"
  },
  {
   "application_number": "ANDA213320",
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    "METFORMIN HYDROCHLORIDE"
   ],
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    "TABLET"
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    "ORAL"
   ],
   "approval_date": "2021-12-03",
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  },
  {
   "application_number": "ANDA215359",
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   "sponsor_name": "SANDOZ",
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   ],
   "active_ingredients": [
    "ARSENIC TRIOXIDE"
   ],
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    "INJECTABLE"
   ],
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    "INJECTION"
   ],
   "approval_date": "2021-12-02",
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  },
  {
   "application_number": "ANDA205742",
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    "GLYCEROL PHENYLBUTYRATE"
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   "dosage_forms": [
    "LIQUID"
   ],
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    "ORAL"
   ],
   "approval_date": "2021-12-02",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA204364",
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   "sponsor_name": "STEVENS J",
   "brand_names": [
    "CINACALCET HYDROCHLORIDE"
   ],
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    "CINACALCET HYDROCHLORIDE"
   ],
   "dosage_forms": [
    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2021-12-02",
   "review_priority": "",
   "submission_class": ""
  },
  {
   "application_number": "ANDA213561",
   "application_type": "ANDA",
   "sponsor_name": "HIKMA PHARMS",
   "brand_names": [
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   ],
   "active_ingredients": [
    "ATROPINE SULFATE"
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    "SOLUTION"
   ],
   "routes": [
    "INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL"
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   "approval_date": "2021-12-01",
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   "submission_class": ""
  },
  {
   "application_number": "ANDA203025",
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   "sponsor_name": "UNICHEM",
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   ],
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    "ARIPIPRAZOLE"
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    "TABLET"
   ],
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   ],
   "approval_date": "2021-12-01",
   "review_priority": "",
   "submission_class": ""
  },
  {
   "application_number": "ANDA213803",
   "application_type": "ANDA",
   "sponsor_name": "TEVA PHARMS USA",
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    "SUNITINIB MALATE"
   ],
   "active_ingredients": [
    "SUNITINIB MALATE"
   ],
   "dosage_forms": [
    "CAPSULE"
   ],
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    "ORAL"
   ],
   "approval_date": "2021-11-30",
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  },
  {
   "application_number": "ANDA209450",
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   ],
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    "LUBIPROSTONE"
   ],
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    "CAPSULE"
   ],
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    "ORAL"
   ],
   "approval_date": "2021-11-30",
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  },
  {
   "application_number": "NDA214907",
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   "sponsor_name": "ON TARGET LABS",
   "brand_names": [
    "CYTALUX"
   ],
   "active_ingredients": [
    "PAFOLACIANINE SODIUM"
   ],
   "dosage_forms": [
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   ],
   "routes": [
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   ],
   "approval_date": "2021-11-29",
   "review_priority": "PRIORITY",
   "submission_class": "Type 1 - New Molecular Entity"
  },
  {
   "application_number": "ANDA214630",
   "application_type": "ANDA",
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   "brand_names": [
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   ],
   "active_ingredients": [
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    "NITROFURANTOIN"
   ],
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    "NITROFURANTOIN, MACROCRYSTALLINE"
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    "CAPSULE"
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    "ORAL"
   ],
   "approval_date": "2021-06-25",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA206617",
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   "sponsor_name": "HIKMA INTL PHARMS",
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    "GEMCITABINE HYDROCHLORIDE"
   ],
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    "GEMCITABINE HYDROCHLORIDE"
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    "INJECTABLE"
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    "INJECTION"
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   "approval_date": "2021-06-25",
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   "submission_class": ""
  },
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   "application_number": "NDA214965",
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   "sponsor_name": "HARROW EYE",
   "brand_names": [
    "VERKAZIA"
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    "CYCLOSPORINE"
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    "EMULSION"
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    "OPHTHALMIC"
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   "approval_date": "2021-06-23",
   "review_priority": "STANDARD",
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  },
  {
   "application_number": "ANDA213762",
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    "ARFORMOTEROL TARTRATE"
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    "ARFORMOTEROL TARTRATE"
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    "SOLUTION"
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    "INHALATION"
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   "approval_date": "2021-06-22",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA213132",
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   "sponsor_name": "GLENMARK PHARMS LTD",
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    "ARFORMOTEROL TARTRATE"
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    "SOLUTION"
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    "INHALATION"
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   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA207306",
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   "sponsor_name": "CIPLA",
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    "ARFORMOTEROL TARTRATE"
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    "SOLUTION"
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    "INHALATION"
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   "review_priority": "STANDARD",
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  },
  {
   "application_number": "ANDA091141",
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   "sponsor_name": "TEVA PHARMS USA INC",
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    "FORMOTEROL FUMARATE"
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    "SOLUTION"
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    "INHALATION"
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   "submission_class": ""
  },
  {
   "application_number": "NDA214358",
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   "sponsor_name": "BOEHRINGER INGELHEIM",
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    "PRADAXA"
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    "DABIGATRAN ETEXILATE MESYLATE"
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    "ORAL"
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   "approval_date": "2021-06-21",
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  },
  {
   "application_number": "NDA210282",
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    "DAPTOMYCIN"
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    "POWDER"
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    "INTRAVENOUS"
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   "approval_date": "2021-06-21",
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  {
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    "OXCARBAZEPINE"
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    "SUSPENSION"
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    "ORAL"
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   "approval_date": "2021-06-21",
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  {
   "application_number": "ANDA211969",
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    "EFINACONAZOLE"
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    "SOLUTION"
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    "TOPICAL"
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  {
   "application_number": "NDA213872",
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    "ASTEPRO ALLERGY",
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    "AZELASTINE HYDROCHLORIDE"
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    "SPRAY, METERED"
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   "routes": [
    "NASAL"
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   "approval_date": "2021-06-17",
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   "submission_class": "Type 8 - Partial Rx to OTC Switch"
  },
  {
   "application_number": "ANDA213906",
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   "sponsor_name": "SUN PHARM INDS INC",
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    "LEVORPHANOL TARTRATE"
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    "TABLET"
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    "ORAL"
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  {
   "application_number": "ANDA211438",
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   "application_number": "NDA212156",
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    "MICAFUNGIN SODIUM"
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    "POWDER"
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    "INTRAVENOUS"
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   "approval_date": "2021-06-16",
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   "application_number": "ANDA213145",
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    "SEVELAMER HYDROCHLORIDE"
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    "TABLET"
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   "submission_class": ""
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  {
   "application_number": "ANDA208740",
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    "EMTRICITABINE",
    "TENOFOVIR DISOPROXIL FUMARATE"
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    "TABLET"
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    "ORAL"
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  {
   "application_number": "ANDA204329",
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    "IBANDRONATE SODIUM"
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    "INTRAVENOUS"
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   "approval_date": "2021-06-16",
   "review_priority": "",
   "submission_class": ""
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   "application_number": "ANDA078509",
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    "EFAVIRENZ"
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    "TABLET"
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    "ORAL"
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   "approval_date": "2021-06-16",
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   "submission_class": ""
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   "application_number": "ANDA214930",
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   "sponsor_name": "ALKEM LABS LTD",
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    "TABLET"
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    "SUBLINGUAL"
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   "approval_date": "2021-06-15",
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  {
   "application_number": "ANDA207685",
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   "application_number": "NDA213536",
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    "SOLUTION"
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   "approval_date": "2021-06-14",
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   "application_number": "NDA213218",
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    "TORSEMIDE"
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    "TABLET"
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   "approval_date": "2021-06-14",
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    "CLOBETASOL PROPIONATE"
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    "TOPICAL"
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   "approval_date": "2021-06-14",
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   "application_number": "ANDA214579",
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    "EPHEDRINE SULFATE"
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    "SOLUTION"
   ],
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    "INTRAVENOUS"
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   "approval_date": "2021-06-14",
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   "submission_class": ""
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  {
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    "ETRAVIRINE"
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    "TABLET"
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    "ORAL"
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   "approval_date": "2021-06-14",
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    "TESTOSTERONE"
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    "SOLUTION, METERED"
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    "TRANSDERMAL"
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   "approval_date": "2021-06-14",
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   "submission_class": ""
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  {
   "application_number": "ANDA212110",
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   "sponsor_name": "ADAPTIS",
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    "AMINOCAPROIC ACID"
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    "AMINOCAPROIC ACID"
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    "TABLET"
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   "routes": [
    "ORAL"
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   "approval_date": "2021-06-14",
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   "submission_class": ""
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  {
   "application_number": "ANDA215069",
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   "sponsor_name": "SCIEGEN PHARMS",
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    "LEVETIRACETAM"
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    "LEVETIRACETAM"
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    "TABLET"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2021-06-11",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA212797",
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   "sponsor_name": "XIAMEN LP PHARM CO",
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    "PRAMIPEXOLE DIHYDROCHLORIDE"
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    "PRAMIPEXOLE DIHYDROCHLORIDE"
   ],
   "dosage_forms": [
    "TABLET, EXTENDED RELEASE"
   ],
   "routes": [
    "ORAL"
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   "approval_date": "2021-06-11",
   "review_priority": "STANDARD",
   "submission_class": ""
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  {
   "application_number": "ANDA211730",
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   "sponsor_name": "APOTEX",
   "brand_names": [
    "FULVESTRANT"
   ],
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    "FULVESTRANT"
   ],
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    "SOLUTION"
   ],
   "routes": [
    "INTRAMUSCULAR"
   ],
   "approval_date": "2021-06-11",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "ANDA209330",
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   "sponsor_name": "BRECKENRIDGE",
   "brand_names": [
    "CARFILZOMIB"
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    "CARFILZOMIB"
   ],
   "dosage_forms": [
    "POWDER"
   ],
   "routes": [
    "INTRAVENOUS"
   ],
   "approval_date": "2021-06-11",
   "review_priority": "STANDARD",
   "submission_class": ""
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  {
   "application_number": "NDA215110",
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   "sponsor_name": "ABBVIE",
   "brand_names": [
    "MAVYRET"
   ],
   "active_ingredients": [
    "GLECAPREVIR",
    "PIBRENTASVIR"
   ],
   "dosage_forms": [
    "PELLETS"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2021-06-10",
   "review_priority": "PRIORITY",
   "submission_class": "Type 3 - New Dosage Form"
  },
  {
   "application_number": "NDA215025",
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   "sponsor_name": "MAIA PHARMS INC",
   "brand_names": [
    "SODIUM PHENYLACETATE AND SODIUM BENZOATE"
   ],
   "active_ingredients": [
    "SODIUM BENZOATE",
    "SODIUM PHENYLACETATE"
   ],
   "dosage_forms": [
    "SOLUTION"
   ],
   "routes": [
    "INTRAVENOUS"
   ],
   "approval_date": "2021-06-10",
   "review_priority": "STANDARD",
   "submission_class": "Type 5 - New Formulation or New Manufacturer"
  },
  {
   "application_number": "NDA214187",
   "application_type": "NDA",
   "sponsor_name": "GILEAD SCIENCES INC",
   "brand_names": [
    "EPCLUSA"
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   "active_ingredients": [
    "SOFOSBUVIR",
    "VELPATASVIR"
   ],
   "dosage_forms": [
    "PELLETS"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2021-06-10",
   "review_priority": "PRIORITY",
   "submission_class": "Type 3 - New Dosage Form"
  },
  {
   "application_number": "ANDA214127",
   "application_type": "ANDA",
   "sponsor_name": "ALKEM LABS LTD",
   "brand_names": [
    "VENLAFAXINE HYDROCHLORIDE"
   ],
   "active_ingredients": [
    "VENLAFAXINE HYDROCHLORIDE"
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   "dosage_forms": [
    "TABLET, EXTENDED RELEASE"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2021-06-10",
   "review_priority": "STANDARD",
   "submission_class": ""
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  {
   "application_number": "NDA212035",
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   "sponsor_name": "ACCORD HLTHCARE",
   "brand_names": [
    "ARGATROBAN IN SODIUM CHLORIDE"
   ],
   "active_ingredients": [
    "ARGATROBAN"
   ],
   "dosage_forms": [
    "SOLUTION"
   ],
   "routes": [
    "INTRAVENOUS"
   ],
   "approval_date": "2021-06-07",
   "review_priority": "STANDARD",
   "submission_class": "Type 5 - New Formulation or New Manufacturer"
  },
  {
   "application_number": "BLA761178",
   "application_type": "BLA",
   "sponsor_name": "BIOGEN INC",
   "brand_names": [
    "ADUHELM"
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   "active_ingredients": [
    "ADUCANUMAB-AVWA"
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   "dosage_forms": [
    "INJECTABLE"
   ],
   "routes": [
    "INJECTION"
   ],
   "approval_date": "2021-06-07",
   "review_priority": "PRIORITY",
   "submission_class": "Type 1 - New Molecular Entity"
  },
  {
   "application_number": "ANDA212160",
   "application_type": "ANDA",
   "sponsor_name": "WINDER LABS LLC",
   "brand_names": [
    "DEXTROAMPHETAMINE SULFATE"
   ],
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    "DEXTROAMPHETAMINE SULFATE"
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   "dosage_forms": [
    "TABLET"
   ],
   "routes": [
    "ORAL"
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   "approval_date": "2021-06-07",
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   "submission_class": ""
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   "application_number": "NDA215256",
   "application_type": "NDA",
   "sponsor_name": "NOVO",
   "brand_names": [
    "WEGOVY",
    "WEGOVY HD",
    "WEGOVY FLEXTOUCH"
   ],
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    "SEMAGLUTIDE"
   ],
   "dosage_forms": [
    "SOLUTION"
   ],
   "routes": [
    "SUBCUTANEOUS"
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   "approval_date": "2021-06-04",
   "review_priority": "PRIORITY",
   "submission_class": "Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated"
  },
  {
   "application_number": "NDA214461",
   "application_type": "NDA",
   "sponsor_name": "EMERGENT BIODEFENSE",
   "brand_names": [
    "TEMBEXA"
   ],
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    "BRINCIDOFOVIR"
   ],
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    "TABLET"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2021-06-04",
   "review_priority": "PRIORITY",
   "submission_class": "Type 2 - New Active Ingredient"
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  {
   "application_number": "NDA214460",
   "application_type": "NDA",
   "sponsor_name": "EMERGENT BIODEFENSE",
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    "TEMBEXA"
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    "BRINCIDOFOVIR"
   ],
   "dosage_forms": [
    "SUSPENSION"
   ],
   "routes": [
    "ORAL"
   ],
   "approval_date": "2021-06-04",
   "review_priority": "PRIORITY",
   "submission_class": "Type 2 - New Active Ingredient"
  },
  {
   "application_number": "ANDA204131",
   "application_type": "ANDA",
   "sponsor_name": "CHARTWELL RX",
   "brand_names": [
    "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE"
   ],
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    "ATOVAQUONE"
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   "application_number": "ANDA209452",
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   "application_number": "ANDA215022",
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   "approval_date": "2021-03-12",
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   "approval_date": "2021-03-11",
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  {
   "application_number": "ANDA211667",
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   "approval_date": "2021-03-11",
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   "approval_date": "2021-03-11",
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   "submission_class": ""
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   "application_number": "NDA212904",
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   "approval_date": "2021-03-10",
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    "DOXYCYCLINE HYCLATE"
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   "approval_date": "2021-03-10",
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   "application_number": "ANDA211910",
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    "NAPROXEN"
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   "approval_date": "2021-03-10",
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    "DEFERASIROX"
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   "approval_date": "2021-03-09",
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   "submission_class": ""
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   "application_number": "ANDA213962",
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   "sponsor_name": "AJANTA PHARMA LTD",
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    "POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%",
    "POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%",
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  },
  {
   "application_number": "ANDA210165",
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   "sponsor_name": "COREPHARMA",
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   ],
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    "PIOGLITAZONE HYDROCHLORIDE"
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    "TABLET"
   ],
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    "ORAL"
   ],
   "approval_date": "2021-01-22",
   "review_priority": "STANDARD",
   "submission_class": ""
  },
  {
   "application_number": "NDA212888",
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   "sponsor_name": "VIIV HLTHCARE",
   "brand_names": [
    "CABENUVA KIT"
   ],
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    "CABOTEGRAVIR",
    "RILPIVIRINE"
   ],
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    "SUSPENSION, EXTENDED RELEASE"
   ],
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    "INTRAMUSCULAR"
   ],
   "approval_date": "2021-01-21",
   "review_priority": "PRIORITY",
   "submission_class": "Type 1 - New Molecular Entity and Type 4 - New Combination"
  },
  {
   "application_number": "NDA212887",
   "application_type": "NDA",
   "sponsor_name": "VIIV HLTHCARE",
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    "VOCABRIA"
   ],
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    "CABOTEGRAVIR SODIUM"
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    "TABLET"
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    "ORAL"
   ],
   "approval_date": "2021-01-21",
   "review_priority": "PRIORITY",
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  },
  {
   "application_number": "ANDA214734",
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   "sponsor_name": "ALEMBIC",
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    "MIDODRINE HYDROCHLORIDE"
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    "TABLET"
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    "ORAL"
   ],
   "approval_date": "2021-01-21",
   "review_priority": "STANDARD",
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  },
  {
   "application_number": "ANDA214235",
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    "ARGATROBAN"
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    "ARGATROBAN"
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    "INJECTABLE"
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    "INJECTION"
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   "approval_date": "2021-01-21",
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  },
  {
   "application_number": "ANDA213927",
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    "VENLAFAXINE HYDROCHLORIDE"
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    "ORAL"
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  {
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    "OSELTAMIVIR PHOSPHATE"
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    "DOXYCYCLINE"
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    "CAPSULE"
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    "ORAL"
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    "VERICIGUAT"
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    "TABLET"
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    "ORAL"
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   "approval_date": "2021-01-19",
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  },
  {
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   "sponsor_name": "AJANTA PHARMA LTD",
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    "LAMOTRIGINE"
   ],
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    "LAMOTRIGINE"
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    "TABLET, ORALLY DISINTEGRATING"
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    "ORAL"
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   "approval_date": "2021-01-19",
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  },
  {
   "application_number": "ANDA208005",
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    "FINGOLIMOD HYDROCHLORIDE"
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    "CAPSULE"
   ],
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    "ORAL"
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  },
  {
   "application_number": "NDA206610",
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    "ACETAMINOPHEN"
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  },
  {
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    "MYCOPHENOLATE MOFETIL HYDROCHLORIDE"
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    "INJECTION"
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  {
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    "METHYLERGONOVINE MALEATE"
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    "INJECTION"
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    "TOPICAL"
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  },
  {
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    "METFORMIN HYDROCHLORIDE"
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    "DOCETAXEL"
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   ],
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   ],
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   ],
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   ],
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   "submission_class": ""
  },
  {
   "application_number": "ANDA091055",
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   ],
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    "TABLET"
   ],
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    "ORAL"
   ],
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   "submission_class": ""
  },
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    "CELECOXIB"
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    "CAPSULE"
   ],
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    "ORAL"
   ],
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  },
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   "application_number": "ANDA210625",
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    "FOSAPREPITANT DIMEGLUMINE"
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    "POWDER"
   ],
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   ],
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    "ACYCLOVIR"
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  },
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    "TESTOSTERONE"
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    "SOLUTION, METERED"
   ],
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    "TRANSDERMAL"
   ],
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  },
  {
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   "sponsor_name": "UNIQUE PHARM",
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    "LORATADINE"
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    "TABLET"
   ],
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    "ORAL"
   ],
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  },
  {
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    "FLUPHENAZINE HYDROCHLORIDE"
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   ],
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  {
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   "sponsor_name": "AVET LIFESCIENCES",
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   ],
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    "PENTAMIDINE ISETHIONATE"
   ],
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   ],
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    "INJECTION"
   ],
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   ],
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    "PHENYLEPHRINE HYDROCHLORIDE"
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   ],
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  {
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   "sponsor_name": "ANI PHARMS",
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    "LEVOTHYROXINE SODIUM"
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   ],
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    "ORAL"
   ],
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   "submission_class": ""
  },
  {
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   ],
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   ],
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  {
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   ],
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    "LIDOCAINE"
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    "CYANOCOBALAMIN"
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   ],
   "routes": [
    "INJECTION"
   ],
   "approval_date": "2021-01-04",
   "review_priority": "STANDARD",
   "submission_class": ""
  }
 ]
}