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 |
|---|---|---|---|
| 25 Jun 2026 | DAPSONE
DAPSONE · Gel |
Generic (ANDA) | Alembic |
| 24 Jun 2026 | ICOSAPENT ETHYL
ICOSAPENT ETHYL · Capsule |
Generic (ANDA) | Aurobindo Pharma Ltd |
| 17 Jun 2026 | ELTROMBOPAG OLAMINE
ELTROMBOPAG OLAMINE · Tablet |
Generic (ANDA) | Actavis Labs Fl |
| 15 Jun 2026 | CABERGOLINE
CABERGOLINE · Tablet |
Generic (ANDA) | Renata |
| 11 Jun 2026 | NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATE · Injectable |
Generic (ANDA) | Nephron |
| 11 Jun 2026 | TRETINOIN
TRETINOIN · Cream |
Generic (ANDA) | Alembic |
| 03 Jun 2026 | TOFACITINIB CITRATE
TOFACITINIB CITRATE · Tablet, Extended Release |
Generic (ANDA) | Apotex |
| 03 Jun 2026 | TOFACITINIB CITRATE
TOFACITINIB CITRATE · Tablet |
Generic (ANDA) | Macleods Pharms Ltd |
| 27 May 2026 | CARBOPROST TROMETHAMINE
CARBOPROST TROMETHAMINE · Injectable |
Generic (ANDA) | Somerset Theraps Llc |
| 21 May 2026 | LACOSAMIDE
LACOSAMIDE · Solution |
Generic (ANDA) | Steranco Hlthcare |
| 07 May 2026 | PALIPERIDONE
PALIPERIDONE · Tablet, Extended Release |
Generic (ANDA) | I3 Pharms |
| 24 Jul 2025 | SDAMLO
AMLODIPINE BESYLATE · For Solution |
New Drug (NDA) | Brillian Pharma |
| 23 May 2025 | BOSUTINIB MONOHYDRATE
BOSUTINIB MONOHYDRATE · Tablet |
Generic (ANDA) | Alembic |
| 14 Apr 2025 | IMATINIB MESYLATE
IMATINIB MESYLATE · Tablet |
Generic (ANDA) | Hetero Labs Ltd V |
| 23 Jan 2025 | SPIRONOLACTONE
SPIRONOLACTONE · Tablet |
Generic (ANDA) | Graviti Pharms |
| 04 Oct 2024 | PYRIDOSTIGMINE BROMIDE
PYRIDOSTIGMINE BROMIDE · Tablet, Extended Release |
New Drug (NDA) | Amneal |
| 13 Sep 2024 | EBGLYSS
LEBRIKIZUMAB-LBKZ · Injectable |
Biologic (BLA) | Eli Lilly And Co |
| 07 Aug 2024 | CREXONT
CARBIDOPA, LEVODOPA · Capsule, Extended Release |
New Drug (NDA) | Impax |
| 03 Jun 2024 | METHOTREXATE SODIUM
METHOTREXATE SODIUM · Tablet |
Generic (ANDA) | Alembic |
| 05 Mar 2024 | TYENNE
TOCILIZUMAB-AAZG · Injectable |
Biologic (BLA) | Fresenius Kabi Usa |
| 05 Mar 2024 | OXCARBAZEPINE
OXCARBAZEPINE · Tablet |
Generic (ANDA) | Rubicon Research |
| 31 Oct 2023 | WEZLANA
USTEKINUMAB-AUUB · Injectable |
Biologic (BLA) | Amgen Inc |
| 07 Aug 2023 | METHOTREXATE SODIUM
METHOTREXATE SODIUM · Tablet |
Generic (ANDA) | Daito |
| 20 Jun 2023 | VYVGART HYTRULO
EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC · Injectable |
Biologic (BLA)Priority | Argenx Bv |
| 15 Jun 2023 | COLUMVI
GLOFITAMAB-GXBM · Injectable |
Biologic (BLA)Priority | Genentech Inc |
| 22 Mar 2023 | ZYNYZ
RETIFANLIMAB-DLWR · Injectable |
Biologic (BLA)Priority | Incyte Corp |
| 22 Dec 2022 | LUNSUMIO VELO
MOSUNETUZUMAB-AXGB · Injectable |
Biologic (BLA)Priority | Genentech Inc |
| 29 Aug 2022 | PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM · Injectable |
Generic (ANDA) | Meitheal |
| 16 Jun 2022 | SKYRIZI
RISANKIZUMAB-RZAA · Injectable |
Biologic (BLA)Priority | Abbvie Inc |
| 30 Dec 2021 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Solution |
Generic (ANDA) | Tris Pharma Inc |
| 02 Jun 2021 | OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE · Solution |
Generic (ANDA) | Quagen |
| 22 Feb 2021 | SUMATRIPTAN
SUMATRIPTAN · Spray |
Generic (ANDA) | Cipla |
| 18 Feb 2021 | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE · Spray, Metered |
Generic (ANDA) | Padagis Israel |
| 30 Sep 2020 | LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE · Tablet |
Generic (ANDA) | Epic Pharma Llc |
| 16 Jul 2020 | OXYCODONE AND ASPIRIN
ASPIRIN, OXYCODONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Epic Pharma Llc |
| 14 Apr 2020 | BUPRENORPHINE
BUPRENORPHINE · Film, Extended Release |
Generic (ANDA) | Amneal |
| 10 Apr 2020 | KOSELUGO
SELUMETINIB SULFATE · Capsule |
New Drug (NDA)Priority | Astrazeneca |
| 10 Mar 2020 | AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Pom Pharma |
| 05 Nov 2019 | ABSORICA LD
ISOTRETINOIN · Capsule |
New Drug (NDA) | Sun Pharm |
| 05 Mar 2019 | SPRAVATO
ESKETAMINE HYDROCHLORIDE · Spray |
New Drug (NDA)Priority | Janssen Pharms |
| 03 Jan 2019 | METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Ascent Pharms Inc |
| 30 Nov 2018 | FYREMADEL
GANIRELIX ACETATE · Injectable |
Generic (ANDA) | Sun Pharm |
| 27 Nov 2018 | ARGATROBAN IN SODIUM CHLORIDE
ARGATROBAN · Solution |
New Drug (NDA) | Eugia Pharma Speclts |
| 16 Nov 2018 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Elite Labs Inc |
| 28 Sep 2018 | ARIKAYCE KIT
AMIKACIN SULFATE · Suspension, Liposomal |
New Drug (NDA)Priority | Insmed Inc |
| 13 Sep 2018 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Aurolife Pharma Llc |
| 30 Mar 2018 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Epic Pharma Llc |
| 30 Oct 2017 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Wes Pharma Inc |
| 25 Sep 2017 | OXYCODONE AND ACETAMINOPHEN
ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Lannett Co Inc |
| 06 Sep 2017 | OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE · Solution |
Generic (ANDA) | Hibrow Hlthcare |
| 30 Aug 2017 | OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE · Solution |
Generic (ANDA) | Ani Pharms |
| 20 Jun 2017 | PIROXICAM
PIROXICAM · Capsule |
Generic (ANDA) | Strides Pharma |
| 28 Apr 2017 | LORAZEPAM
LORAZEPAM · Injectable |
Generic (ANDA) | Rising |
| 14 Nov 2016 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Novel Labs Inc |
| 14 Nov 2016 | MORPHINE SULFATE
MORPHINE SULFATE · Solution |
Generic (ANDA) | Pharm Assoc |
| 30 Sep 2016 | ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE
ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE · Tablet |
Generic (ANDA) | Pharmobedient |
| 23 Jun 2016 | MORPHINE SULFATE
MORPHINE SULFATE · Tablet, Extended Release |
Generic (ANDA) | Epic Pharma Llc |
| 13 May 2016 | HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Aurolife Pharma Llc |
| 28 Apr 2016 | AZACITIDINE
AZACITIDINE · Powder |
Generic (ANDA) | Pharmobedient |
| 26 Apr 2016 | XTAMPZA ER
OXYCODONE · Capsule, Extended Release |
New Drug (NDA) | Collegium Pharm Inc |
| 18 Nov 2015 | RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM · Tablet, Delayed Release |
Generic (ANDA) | Rubicon Research |
| 01 Jun 2015 | OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE · Solution |
Generic (ANDA) | Ani Pharms |
| 27 May 2015 | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ETHINYL ESTRADIOL, LEVONORGESTREL · Tablet |
Generic (ANDA) | Xiromed |
| 29 Apr 2015 | OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE · Solution |
Generic (ANDA) | Novel Labs Inc |
| 08 Apr 2015 | VALACYCLOVIR HYDROCHLORIDE
VALACYCLOVIR HYDROCHLORIDE · Tablet |
Generic (ANDA) | Hetero Labs Ltd V |
| 06 Apr 2015 | MORPHINE SULFATE
MORPHINE SULFATE · Tablet, Extended Release |
Generic (ANDA) | Actavis Elizabeth |
| 29 Dec 2014 | MORPHINE SULFATE
MORPHINE SULFATE · Capsule, Extended Release |
Generic (ANDA) | Teva Pharms Usa |
| 18 Nov 2014 | BRIMONIDINE TARTRATE
BRIMONIDINE TARTRATE · Solution/drops |
Generic (ANDA) | Regcon Holdings |
| 28 Aug 2014 | OXYCODONE AND ACETAMINOPHEN
ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Rhodes Pharms |
| 13 Jun 2014 | CODEINE SULFATE
CODEINE SULFATE · Tablet |
Generic (ANDA) | Lannett Co Inc |
| 05 Mar 2014 | DOXYCYCLINE
DOXYCYCLINE · Capsule |
Generic (ANDA) | Lupin |
| 18 Dec 2013 | ADRENALIN
EPINEPHRINE · Solution |
New Drug (NDA) | Ph Health |
| 29 Nov 2013 | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM · Tablet |
Generic (ANDA) | Mylan |
| 30 Oct 2013 | MORPHINE SULFATE
MORPHINE SULFATE · Solution |
New Drug (NDA) | Fresenius Kabi Usa |
| 11 Jul 2013 | OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Actavis Elizabeth |
| 27 Jun 2012 | TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Ph Health |
| 05 Jan 2012 | ARGATROBAN
ARGATROBAN · Injectable |
New Drug (NDA) | Hikma Pharm Co Ltd |
| 21 Dec 2010 | OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Impax Labs |
| 06 Apr 2010 | LOSARTAN POTASSIUM
LOSARTAN POTASSIUM · Tablet |
Generic (ANDA) | Teva |
| 29 Jan 2009 | DIVALPROEX SODIUM
DIVALPROEX SODIUM · Tablet, Extended Release |
Generic (ANDA) | Mylan |
| 26 Sep 2008 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ACETAMINOPHEN, TRAMADOL HYDROCHLORIDE · Tablet |
Generic (ANDA) | Rising |
| 17 Mar 2008 | MORPHINE SULFATE
MORPHINE SULFATE · Solution |
New Drug (NDA) | Hikma |
| 17 Mar 2008 | MORPHINE SULFATE
MORPHINE SULFATE · Tablet |
New Drug (NDA) | Hikma |
| 30 Dec 2005 | OXYCODONE AND ACETAMINOPHEN
ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Mikart |
| 31 May 2000 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Strides Pharma Intl |
| 18 Apr 2000 | ZYVOX
LINEZOLID · Tablet |
New Drug (NDA)Priority | Pfizer |
| 18 Apr 2000 | ZYVOX
LINEZOLID · Solution |
New Drug (NDA)Priority | Pfizer |
| 18 Apr 2000 | ZYVOX
LINEZOLID · For Suspension |
New Drug (NDA)Priority | Pfizer |
| 25 Jun 1999 | PERCOCET
ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Ozantri |
| 28 May 1999 | MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Epic Pharma Llc |
| 28 Oct 1998 | MORPHINE SULFATE
MORPHINE SULFATE · Tablet, Extended Release |
Generic (ANDA) | Strides Pharma Intl |
| 29 Jul 1998 | HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Hikma |
| 08 Dec 1995 | ZYRTEC HIVES
CETIRIZINE HYDROCHLORIDE · Tablet |
New Drug (NDA) | Kenvue Brands |
| 01 Aug 1994 | METHOTREXATE SODIUM
METHOTREXATE SODIUM · Tablet |
Generic (ANDA) | Hikma |
| 29 Apr 1993 | VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
VANCOMYCIN HYDROCHLORIDE · Solution |
New Drug (NDA) | Baxter Hlthcare |
| 30 Dec 1991 | MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE · Capsule |
Generic (ANDA) | Watson Labs |
| 28 Jan 1991 | ALTACE
RAMIPRIL · Capsule |
New Drug (NDA) | King Pharms Llc |
| 26 May 1982 | OXYCODONE AND ASPIRIN
ASPIRIN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE · Tablet |
Generic (ANDA) | Sun Pharm Industries |
| 22 May 1981 | METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE · Solution |
Generic (ANDA) | Hikma |
| 21 Dec 1973 | DEXTROSE 5% IN PLASTIC CONTAINER
DEXTROSE · Injectable |
New Drug (NDA) | B Braun |
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. Cross-reference the Irish market in our Irish Medicines Database.