Every original FDA approval from the last 60 days - new drugs, biologics and generics - with sponsor, active ingredient and review priority. The free tracker for what's newly approvable in the world's largest pharma market.
| Approved | Product | Type | Sponsor |
|---|---|---|---|
| 04 Sep 2026 | ETCAMAH
CAMIZESTRANT · Tablet |
New Drug (NDA) | Astrazeneca Pharmaceuticals, Lp |
| 28 Aug 2026 | CALCIUM GLUCONATE IN SODIUM CHLORIDE
CALCIUM GLUCONATE · Solution |
Generic (ANDA) | Milla Pharms |
| 14 Aug 2026 | CABOZANTINIB S-MALATE
CABOZANTINIB S-MALATE · Tablet |
Generic (ANDA) | Msn |
| 10 Aug 2026 | BRIVARACETAM
BRIVARACETAM · Solution |
Generic (ANDA) | Aurobindo Pharma |
| 07 Aug 2026 | VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE · For Solution |
Generic (ANDA) | Aurobindo Pharma |
| 30 Jul 2026 | FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Dr Reddys |
| 29 Jul 2026 | GLYCOPHOS
SODIUM GLYCEROPHOSPHATE · Solution |
New Drug (NDA) | Fresenius Kabi Usa |
| 28 Jul 2026 | SUGAMMADEX SODIUM
SUGAMMADEX SODIUM · Solution |
Generic (ANDA) | Zenara |
| 28 Jul 2026 | SUGAMMADEX SODIUM
SUGAMMADEX SODIUM · Solution |
Generic (ANDA) | Sandoz |
| 28 Jul 2026 | SUGAMMADEX SODIUM
SUGAMMADEX SODIUM · Solution |
Generic (ANDA) | Sun Pharm Inds Inc |
| 28 Jul 2026 | SUGAMMADEX SODIUM
SUGAMMADEX SODIUM · Solution |
Generic (ANDA) | Mylan |
| 28 Jul 2026 | SUGAMMADEX SODIUM
SUGAMMADEX SODIUM · Solution |
Generic (ANDA) | Qilu Pharm Hainan |
| 28 Jul 2026 | SUGAMMADEX SODIUM
SUGAMMADEX SODIUM · Solution |
Generic (ANDA) | Lupin |
| 28 Jul 2026 | SUGAMMADEX SODIUM
SUGAMMADEX SODIUM · Solution |
Generic (ANDA) | Msn |
| 27 Jul 2026 | DIAZEPAM
DIAZEPAM · Injectable |
Generic (ANDA) | Lupin |
| 24 Jul 2026 | SIMTRIYO
CENTANAFADINE HYDROCHLORIDE · Capsule, Extended Release |
New Drug (NDA)Priority | Otsuka Pharmaceutical Co Ltd |
| 01 Jun 2026 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · For Suspension |
Generic (ANDA) | Concord Biotech Ltd |
| 08 Aug 2025 | HERNEXEOS
ZONGERTINIB · Tablet |
New Drug (NDA)Priority | Boehringer Ingelheim |
| 18 Oct 2024 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Aurobindo Pharma |
| 19 Mar 2024 | TRYVIO
APROCITENTAN · Tablet |
New Drug (NDA) | Idorsia |
| 13 Mar 2024 | TEVIMBRA
TISLELIZUMAB-JSGR · Injection |
Biologic (BLA) | Beigene |
| 27 Nov 2023 | OGSIVEO
NIROGACESTAT HYDROBROMIDE · Tablet |
New Drug (NDA)Priority | Springworks |
| 15 Sep 2023 | OJJAARA
MOMELOTINIB DIHYDROCHLORIDE · Tablet |
New Drug (NDA) | Glaxosmithkline |
| 11 Sep 2023 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · For Suspension |
Generic (ANDA) | Rising |
| 31 Jul 2023 | SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, SAXAGLIPTIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Mylan |
| 14 Apr 2023 | NITROFURANTOIN
NITROFURANTOIN · Suspension |
Generic (ANDA) | Novitium Pharma |
| 09 Mar 2023 | ZAVZPRET
ZAVEGEPANT HYDROCHLORIDE · Spray, Metered |
New Drug (NDA) | Pfizer |
| 10 Jan 2023 | NELARABINE
NELARABINE · Injectable |
Generic (ANDA) | Meitheal |
| 23 Dec 2022 | MYCOPHENOLATE MOFETIL HYDROCHLORIDE
MYCOPHENOLATE MOFETIL HYDROCHLORIDE · Injectable |
Generic (ANDA) | Onesource Specialty |
| 22 Dec 2022 | SUNLENCA
LENACAPAVIR SODIUM · Solution |
New Drug (NDA)Priority | Gilead Sciences Inc |
| 22 Dec 2022 | SUNLENCA
LENACAPAVIR SODIUM · Tablet |
New Drug (NDA)Priority | Gilead Sciences Inc |
| 02 Jun 2022 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE · Film |
Generic (ANDA) | Difgen Pharms |
| 12 Nov 2021 | BESREMI
ROPEGINTERFERON ALFA-2B-NJFT · Injectable |
Biologic (BLA) | Pharmaessentia Corp |
| 17 Sep 2021 | BYOOVIZ
RANIBIZUMAB-NUNA · Injectable |
Biologic (BLA) | Samsung Bioepis Co Ltd |
| 06 Jul 2021 | PREGABALIN
PREGABALIN · Tablet, Extended Release |
Generic (ANDA) | Alvogen |
| 07 Jun 2021 | ARGATROBAN IN SODIUM CHLORIDE
ARGATROBAN · Solution |
New Drug (NDA) | Accord Hlthcare |
| 05 Mar 2021 | MYCOPHENOLATE MOFETIL HYDROCHLORIDE
MYCOPHENOLATE MOFETIL HYDROCHLORIDE · Injectable |
Generic (ANDA) | Amneal |
| 06 Nov 2020 | METOPROLOL SUCCINATE
METOPROLOL SUCCINATE · Tablet, Extended Release |
Generic (ANDA) | Hetero Labs Ltd Iii |
| 02 Nov 2020 | METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE · Concentrate |
Generic (ANDA) | Lannett Co Inc |
| 08 Sep 2020 | FOSAPREPITANT DIMEGLUMINE
FOSAPREPITANT DIMEGLUMINE · Powder |
Generic (ANDA) | Qilu Pharm Hainan |
| 31 Jul 2020 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · Tablet |
Generic (ANDA) | Concord Biotech Ltd |
| 05 Sep 2019 | FOSAPREPITANT DIMEGLUMINE
FOSAPREPITANT DIMEGLUMINE · Powder |
Generic (ANDA) | Mylan Labs Ltd |
| 24 Apr 2019 | ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM · Tablet |
Generic (ANDA) | Sciegen Pharms |
| 12 Feb 2019 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · For Suspension |
Generic (ANDA) | Vistapharm Llc |
| 24 Jan 2019 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE · Film |
Generic (ANDA) | Alvogen |
| 27 Dec 2018 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Qingdao Baheal Pharm |
| 30 Nov 2018 | LAMOTRIGINE
LAMOTRIGINE · Tablet, Extended Release |
Generic (ANDA) | Amneal Pharms |
| 02 Nov 2018 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Novast Labs |
| 12 Oct 2018 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Sunshine |
| 24 Sep 2018 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Yichang Humanwell |
| 18 Jul 2018 | SPIRONOLACTONE
SPIRONOLACTONE · Tablet |
Generic (ANDA) | Zydus Pharms |
| 16 Mar 2018 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Granules |
| 20 Dec 2017 | MACRILEN
MACIMORELIN ACETATE · For Solution |
New Drug (NDA) | Aeterna Zentaris |
| 18 Jan 2017 | ASPIRIN AND DIPYRIDAMOLE
ASPIRIN, DIPYRIDAMOLE · Capsule, Extended Release |
Generic (ANDA) | Ph Health |
| 09 Dec 2016 | SYNJARDY XR
EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
New Drug (NDA) | Boehringer Ingelheim |
| 22 Nov 2016 | METAXALONE
METAXALONE · Tablet |
Generic (ANDA) | Lannett Co Inc |
| 31 Oct 2016 | ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM · Tablet |
Generic (ANDA) | Torrent |
| 05 Aug 2016 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Sun Pharm |
| 19 Jul 2016 | ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM · Tablet |
Generic (ANDA) | Glenmark Speclt |
| 19 Jul 2016 | ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM · Tablet |
Generic (ANDA) | Sun Pharm |
| 19 Jul 2016 | ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM · Tablet |
Generic (ANDA) | Aurobindo Pharma Ltd |
| 11 Jul 2016 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Cspc Ouyi |
| 17 Jun 2016 | LAMOTRIGINE
LAMOTRIGINE · Tablet, Orally Disintegrating |
Generic (ANDA) | Sciegen Pharms |
| 29 Feb 2016 | GLYBURIDE AND METFORMIN HYDROCHLORIDE
GLYBURIDE, METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Zydus Pharms |
| 16 Oct 2015 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Ethypharm |
| 07 Aug 2015 | CEFAZOLIN IN DEXTROSE
CEFAZOLIN SODIUM · Solution |
New Drug (NDA) | Baxter Hlthcare Corp |
| 19 Feb 2015 | BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Actavis Elizabeth |
| 22 Dec 2014 | OPDIVO
NIVOLUMAB · Injectable |
Biologic (BLA)Priority | Bristol Myers Squibb |
| 08 Sep 2014 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Teva Pharms Usa |
| 28 Aug 2014 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Zydus Hlthcare |
| 28 Apr 2014 | PURIXAN
MERCAPTOPURINE · Suspension |
New Drug (NDA) | Nova Labs Ltd |
| 06 Mar 2014 | SPIRONOLACTONE
SPIRONOLACTONE · Tablet |
Generic (ANDA) | Aurobindo Pharma |
| 15 Nov 2013 | ACYCLOVIR
ACYCLOVIR · Tablet |
Generic (ANDA) | Cadila Pharms Ltd |
| 12 Aug 2013 | TIVICAY
DOLUTEGRAVIR SODIUM · Tablet |
New Drug (NDA)Priority | Viiv Hlthcare |
| 04 Feb 2013 | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
DOXORUBICIN HYDROCHLORIDE · Injectable, Liposomal |
Generic (ANDA) | Sun Pharm |
| 23 Apr 2012 | OLANZAPINE
OLANZAPINE · Tablet |
Generic (ANDA) | Dr Reddys Labs Ltd |
| 16 Nov 2011 | JAKAFI
RUXOLITINIB PHOSPHATE · Tablet |
New Drug (NDA)Priority | Incyte Corp |
| 25 Mar 2011 | YERVOY
IPILIMUMAB · Injectable |
Biologic (BLA)Priority | Bristol Myers Squibb |
| 09 Mar 2011 | BENLYSTA
BELIMUMAB · Injectable |
Biologic (BLA)Priority | Human Genome Sciences Inc. |
| 01 Nov 2010 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Alkem |
| 14 Sep 2010 | KRYSTEXXA
PEGLOTICASE · Injectable |
Biologic (BLA)Priority | Horizon Pharma |
| 03 Jan 2008 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Amneal Pharms Ny |
| 21 Dec 2005 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Sun Pharm Industries |
| 08 Sep 2005 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Pharmobedient |
| 03 Jun 2005 | GLUMETZA
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
New Drug (NDA) | Santarus Inc |
| 21 Apr 2005 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Zydus Lifesciences |
| 18 Apr 2005 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Zydus Pharms Usa |
| 12 Apr 2005 | CICLOPIROX
CICLOPIROX · Cream |
Generic (ANDA) | Sun Pharma Canada |
| 29 Mar 2005 | BARACLUDE
ENTECAVIR · Solution |
New Drug (NDA)Priority | Bristol Myers Squibb |
| 29 Mar 2005 | BARACLUDE
ENTECAVIR · Tablet |
New Drug (NDA)Priority | Bristol Myers Squibb |
| 27 Jan 2005 | GLYBURIDE AND METFORMIN HYDROCHLORIDE
GLYBURIDE, METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Teva |
| 14 Jan 2005 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Aurobindo |
| 14 Dec 2004 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Sandoz |
| 30 Jul 2004 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Impax Labs |
| 18 Jun 2004 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Teva |
| 09 Jun 2004 | CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Watson Labs |
| 19 Oct 2000 | DOXAZOSIN MESYLATE
DOXAZOSIN MESYLATE · Tablet |
Generic (ANDA) | Aurobindo Pharma Usa |
| 26 Feb 1999 | METHOTREXATE PRESERVATIVE FREE
METHOTREXATE SODIUM · Injectable |
Generic (ANDA) | Fresenius Kabi Usa |
| 22 Jul 1985 | AUGMENTIN '125'
AMOXICILLIN, CLAVULANATE POTASSIUM · Tablet, Chewable |
New Drug (NDA) | Us Antibiotics |
| 24 Dec 1984 | DYNA-HEX 4
CHLORHEXIDINE GLUCONATE · Solution |
New Drug (NDA) | Xttrium |
Source: openFDA Drugs@FDA API, U.S. Food & Drug Administration - original (ORIG) approvals only; supplement approvals excluded. openFDA data is provided as-is and unvalidated. Compare the EU market in our EMA Approvals Tracker, see the FDA Recall Tracker for enforcement reports, or cross-reference the Irish market in the Irish Medicines Database.