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 |
|---|---|---|---|
| 05 Aug 2026 | ORZEYFUL
OVEPOREXTON · Tablet |
New Drug (NDA)Priority | Takeda Pharms Usa |
| 29 Jul 2026 | QLONILIK
CLONIDINE HYDROCHLORIDE · Solution |
New Drug (NDA) | Cmp Dev Llc |
| 22 Jul 2026 | TOPIRAMATE
TOPIRAMATE · Capsule, Extended Release |
Generic (ANDA) | Biocon Pharma |
| 22 Jul 2026 | ADAPALENE AND BENZOYL PEROXIDE
ADAPALENE, BENZOYL PEROXIDE · Gel |
Generic (ANDA) | Aurobindo Pharma Ltd |
| 21 Jul 2026 | TOLVAPTAN
TOLVAPTAN · Tablet |
Generic (ANDA) | Teva Pharms Inc |
| 19 Jul 2026 | AIR
AIR · Gas |
New Drug (NDA) | Noble Gas Solutions Inc. |
| 17 Jul 2026 | DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE · Capsule |
Generic (ANDA) | Rubicon Research |
| 14 Jul 2026 | REVTORPYK
GEDATOLISIB · Powder |
New Drug (NDA)Priority | Celcuity |
| 14 Jul 2026 | PROPOFOL
PROPOFOL · Injectable |
Generic (ANDA) | Anthea Pharma |
| 14 Jul 2026 | AFATINIB DIMALEATE
AFATINIB DIMALEATE · Tablet |
Generic (ANDA) | Hetero Labs Ltd V |
| 10 Jul 2026 | RILPIVIRINE HYDROCHLORIDE
RILPIVIRINE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Laurus |
| 09 Jul 2026 | SARCLISA ESCENA
ISATUXIMAB-IRFC · Vial |
Biologic (BLA) | Sanofi-aventis U.s. Llc |
| 08 Jul 2026 | CYANOCOBALAMIN
CYANOCOBALAMIN · Injectable |
Generic (ANDA) | Aspiro |
| 01 Jul 2026 | RIVAROXABAN
RIVAROXABAN · Tablet |
Generic (ANDA) | Mankind Pharma |
| 30 Jun 2026 | RIVAROXABAN
RIVAROXABAN · Tablet |
Generic (ANDA) | Micro Labs |
| 29 Jun 2026 | PRUCALOPRIDE SUCCINATE
PRUCALOPRIDE SUCCINATE · Tablet |
Generic (ANDA) | Micro Labs |
| 25 Jun 2026 | FERRIC CARBOXYMALTOSE
FERRIC CARBOXYMALTOSE · Solution |
Generic (ANDA) | Mylan |
| 25 Jun 2026 | TOFACITINIB CITRATE
TOFACITINIB CITRATE · Tablet, Extended Release |
Generic (ANDA) | Sciegen Pharms |
| 23 Jun 2026 | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE · Syrup |
Generic (ANDA) | Rubicon Research |
| 29 May 2026 | CAVHANZA
NILOTINIB · Tablet, Orally Disintegrating |
New Drug (NDA) | Flex Pharma |
| 01 Apr 2026 | FOUNDAYO
ORFORGLIPRON CALCIUM · Tablet |
New Drug (NDA) | Eli Lilly And Co |
| 02 Jul 2025 | LYNOZYFIC
LINVOSELTAMAB-GCPT · Solution |
Biologic (BLA)Priority | Rengeneron Pharmaceuticals, Inc. |
| 27 Jun 2025 | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
DOXORUBICIN HYDROCHLORIDE · Injectable, Liposomal |
Generic (ANDA) | Alembic |
| 15 Apr 2025 | MEZOFY
ARIPIPRAZOLE · Film |
New Drug (NDA) | Cmg Pharm Co Ltd |
| 31 Jan 2025 | TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Macleods Pharms |
| 26 Sep 2024 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · For Suspension |
Generic (ANDA) | Aurobindo Pharma Ltd |
| 09 Aug 2024 | YORVIPATH
PALOPEGTERIPARATIDE · Solution |
New Drug (NDA)Priority | Ascendis Pharma Bone |
| 03 Apr 2024 | ZEVTERA
CEFTOBIPROLE MEDOCARIL SODIUM · Powder |
New Drug (NDA)Priority | Istx |
| 14 Mar 2024 | REZDIFFRA
RESMETIROM · Tablet |
New Drug (NDA)Priority | Madrigal |
| 14 Feb 2024 | OXCARBAZEPINE
OXCARBAZEPINE · Suspension |
Generic (ANDA) | Kanchan Hlthcare |
| 05 Dec 2023 | FABHALTA
IPTACOPAN HYDROCHLORIDE · Capsule |
New Drug (NDA)Priority | Novartis |
| 14 Aug 2023 | HEPZATO
MELPHALAN HYDROCHLORIDE · Powder |
New Drug (NDA) | Delcath Systems Inc |
| 22 Mar 2023 | REZZAYO
REZAFUNGIN ACETATE · Powder |
New Drug (NDA)Priority | Mundipharma |
| 21 Sep 2022 | CARBIDOPA AND LEVODOPA
CARBIDOPA, LEVODOPA · Tablet |
Generic (ANDA) | Rubicon Research |
| 01 Jul 2022 | ACYCLOVIR
ACYCLOVIR · Suspension |
Generic (ANDA) | Hetero Labs Ltd Iii |
| 17 Jun 2022 | PHEBURANE
SODIUM PHENYLBUTYRATE · Pellets |
New Drug (NDA) | Medunik |
| 21 Sep 2021 | OPZELURA
RUXOLITINIB PHOSPHATE · Cream |
New Drug (NDA)Priority | Incyte Corp |
| 12 Apr 2021 | ISOTRETINOIN
ISOTRETINOIN · Capsule |
Generic (ANDA) | Upsher Smith Labs |
| 12 Feb 2021 | MORPHINE SULFATE
MORPHINE SULFATE · Solution |
Generic (ANDA) | Winder Labs Llc |
| 15 Jan 2021 | MYCOPHENOLATE MOFETIL HYDROCHLORIDE
MYCOPHENOLATE MOFETIL HYDROCHLORIDE · Injectable |
Generic (ANDA) | Meitheal |
| 23 Sep 2020 | HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE · Tablet, Extended Release |
Generic (ANDA) | Ascent Pharms Inc |
| 07 May 2019 | DESVENLAFAXINE SUCCINATE
DESVENLAFAXINE SUCCINATE · Tablet, Extended Release |
Generic (ANDA) | Platinum |
| 26 Apr 2019 | BOSENTAN
BOSENTAN · Tablet |
Generic (ANDA) | Amneal Pharms Co |
| 30 Apr 2018 | OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE · Solution |
Generic (ANDA) | Specgx Llc |
| 16 Nov 2017 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · Tablet |
Generic (ANDA) | Zhejiang Hisun Pharm |
| 13 Nov 2017 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · Capsule |
Generic (ANDA) | Zhejiang Hisun Pharm |
| 31 Aug 2017 | MYCOPHENOLATE MOFETIL HYDROCHLORIDE
MYCOPHENOLATE MOFETIL HYDROCHLORIDE · Injectable |
Generic (ANDA) | Zydus Pharms |
| 15 Aug 2017 | OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE · Solution |
Generic (ANDA) | Pharm Assoc |
| 23 Jun 2017 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Amneal Pharms Ny |
| 21 Jun 2017 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Abhai Llc |
| 21 Jun 2017 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Abhai Llc |
| 28 Apr 2017 | TYMLOS
ABALOPARATIDE · Solution |
New Drug (NDA) | Radius |
| 21 Mar 2017 | ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM · Tablet |
Generic (ANDA) | Alkem Labs Ltd |
| 13 Mar 2017 | KISQALI
RIBOCICLIB SUCCINATE · Tablet |
New Drug (NDA)Priority | Novartis |
| 13 Dec 2016 | OXYCODONE AND ACETAMINOPHEN
ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Sanaluz |
| 12 Jul 2016 | MORPHINE SULFATE
MORPHINE SULFATE · Solution |
Generic (ANDA) | Rhodes Pharms |
| 15 Jun 2016 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Strides Pharma Intl |
| 26 Apr 2016 | OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Aurolife Pharma Llc |
| 16 Feb 2016 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE · Capsule, Extended Release |
Generic (ANDA) | Impax Labs |
| 16 Jun 2015 | OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE · Solution |
Generic (ANDA) | Pharmobedient |
| 10 Jun 2015 | BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Rubicon Research |
| 19 Aug 2014 | MYCOPHENOLATE SODIUM
MYCOPHENOLATE SODIUM · Tablet, Delayed Release |
Generic (ANDA) | Apotex Inc |
| 08 Oct 2013 | ADEMPAS
RIOCIGUAT · Tablet |
New Drug (NDA) | Bayer Hlthcare |
| 13 Jun 2013 | MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL · Capsule |
Generic (ANDA) | Alkem Labs Ltd |
| 30 Jun 2011 | CODEINE SULFATE
CODEINE SULFATE · Solution |
New Drug (NDA) | Hikma |
| 24 Jun 2011 | LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM · Powder |
New Drug (NDA) | Fresenius Kabi Usa |
| 23 Jun 2010 | HYDROCODONE BITARTRATE AND IBUPROFEN
HYDROCODONE BITARTRATE, IBUPROFEN · Tablet |
Generic (ANDA) | Ani Pharms |
| 22 Apr 2010 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Granules India |
| 24 Aug 2009 | OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Epic Pharma Llc |
| 20 Nov 2008 | NUCYNTA
TAPENTADOL HYDROCHLORIDE · Tablet |
New Drug (NDA) | Collegium Pharm Inc |
| 20 Oct 2008 | FENTANYL-75
FENTANYL · Film, Extended Release |
Generic (ANDA) | Difgen Pharms |
| 30 Oct 2007 | FINASTERIDE
FINASTERIDE · Tablet |
Generic (ANDA) | Aurobindo Pharma |
| 25 Aug 2006 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Amneal Pharms Ny |
| 23 Dec 2004 | HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Specgx Llc |
| 10 Jun 2004 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE · Capsule |
Generic (ANDA) | Lgm Pharma |
| 09 Jun 2004 | CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Hikma |
| 25 Sep 2002 | AUGMENTIN XR
AMOXICILLIN, CLAVULANATE POTASSIUM · Tablet, Extended Release |
New Drug (NDA) | Us Antibiotics |
| 08 Aug 2002 | MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Sun Pharm Inds Inc |
| 22 Apr 2002 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE · Capsule |
Generic (ANDA) | Pharmobedient |
| 25 Jan 2002 | METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE · Tablet |
Generic (ANDA) | Watson Labs Florida |
| 22 Jun 2001 | AUGMENTIN ES-600
AMOXICILLIN, CLAVULANATE POTASSIUM · For Suspension |
New Drug (NDA) | Us Antibiotics |
| 31 May 2001 | ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN, CODEINE PHOSPHATE · Tablet |
Generic (ANDA) | Specgx Llc |
| 20 Oct 2000 | ANEXSIA 5/325
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Specgx Llc |
| 08 Sep 2000 | ANEXSIA 7.5/325
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Specgx Llc |
| 26 Jul 2000 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN, HYDROCODONE BITARTRATE · Tablet |
Generic (ANDA) | Specgx Llc |
| 05 Mar 1999 | BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE · Capsule |
Generic (ANDA) | Novitium Pharma |
| 01 Oct 1998 | CELLCEPT
MYCOPHENOLATE MOFETIL · For Suspension |
New Drug (NDA) | Roche Palo |
| 30 Sep 1997 | AVAPRO
IRBESARTAN · Tablet |
New Drug (NDA) | Sanofi Aventis Us |
| 12 Mar 1997 | MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Hikma |
| 21 Jan 1997 | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE, PENTAZOCINE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Watson Labs |
| 30 Jul 1996 | OXYCODONE AND ACETAMINOPHEN
ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE · Tablet |
Generic (ANDA) | Ph Health |
| 26 Apr 1996 | ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN, CODEINE PHOSPHATE · Solution |
Generic (ANDA) | Pai Holdings |
| 25 Mar 1996 | TEGRETOL-XR
CARBAMAZEPINE · Tablet, Extended Release |
New Drug (NDA) | Novartis |
| 07 Mar 1994 | STIMATE
DESMOPRESSIN ACETATE · Spray, Metered |
New Drug (NDA) | Ferring Pharms Inc |
| 07 Dec 1992 | DILAUDID
HYDROMORPHONE HYDROCHLORIDE · Solution |
New Drug (NDA) | Rhodes Pharms |
| 30 Sep 1988 | ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN, CODEINE PHOSPHATE · Tablet |
Generic (ANDA) | Strides Pharma Intl |
| 03 Dec 1986 | ROXICET
ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE · Solution |
Generic (ANDA) | Hikma |
| 30 Aug 1982 | METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE · Solution |
Generic (ANDA) | Hikma |
| 11 Mar 1968 | TEGRETOL
CARBAMAZEPINE · Tablet |
New Drug (NDA)Priority | Novartis |
| 12 Apr 1950 | PERCODAN
ASPIRIN, OXYCODONE HYDROCHLORIDE · Tablet |
New Drug (NDA) | Endo Operations |
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.