FDA Approved Drugs
Last published 1d ago
- 1d agoApproval of POHERDY, BLA #761450FDA Approved DrugsApproval Date: 11/10/2026 Drug Name: POHERDY, BLA #761450 Submission: SUPPL-2 Active Ingredients: PERTUZUMAB-DPZB Company: SHANGHAI HENLIUS BIOTECH Submission Status: Approval Application Number: 761450
- 2d agoApproval of OXDERYS, NDA #221093 (Type 5 - New Formulation or New Manufacturer)FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: OXDERYS, NDA #221093 Submission: ORIG-1 Active Ingredients: DOXORUBICIN HYDROCHLORIDE Company: AVYXA HOLDINGS Submission Status: Approval Submission Classification: Type 5 - New Formulation or New Manufacturer Application Number: 221093
- 2d agoApproval of MYDRIACYL, ANDA #084306 (Labeling)FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: MYDRIACYL, ANDA #084306 Submission: SUPPL-49 Active Ingredients: TROPICAMIDE Company: ALCON LABS INC Submission Status: Approval Submission Classification: Labeling Application Number: 084306
- 2d agoApproval of ASENAPINE MALEATE, ANDA #205960 (Labeling)FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: ASENAPINE MALEATE, ANDA #205960 Submission: SUPPL-6 Active Ingredients: ASENAPINE MALEATE Company: BRECKENRIDGE Submission Status: Approval Submission Classification: Labeling Application Number: 205960
- 2d agoApproval of CARBIDOPA AND LEVODOPA, ANDA #214092 (Labeling)FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: CARBIDOPA AND LEVODOPA, ANDA #214092 Submission: SUPPL-11 Active Ingredients: CARBIDOPA; LEVODOPA Company: SCIEGEN PHARMS Submission Status: Approval Submission Classification: Labeling Application Number: 214092
- 2d agoApproval of GABAPENTIN, ANDA #217682 (Labeling)FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: GABAPENTIN, ANDA #217682 Submission: SUPPL-3 Active Ingredients: GABAPENTIN Company: ANNORA PHARMA Submission Status: Approval Submission Classification: Labeling Application Number: 217682
- 2d agoApproval of AMABELZ, ANDA #203339 (Manufacturing (CMC))FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: AMABELZ, ANDA #203339 Submission: SUPPL-18 Active Ingredients: ESTRADIOL; NORETHINDRONE ACETATE Company: LUPIN Submission Status: Approval Submission Classification: Manufacturing (CMC) Application Number: 203339
- 2d agoApproval of VALSARTAN AND HYDROCHLOROTHIAZIDE, ANDA #203000 (Manufacturing (CMC))FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: VALSARTAN AND HYDROCHLOROTHIAZIDE, ANDA #203000 Submission: SUPPL-4 Active Ingredients: HYDROCHLOROTHIAZIDE; VALSARTAN Company: ZYDUS LIFESCIENCES Submission Status: Approval Submission Classification: Manufacturing (CMC) Application Number: 203000
- 2d agoApproval of MULTIBIC, NDA #219457 (Type 2 - New Active Ingredient)FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: MULTIBIC, NDA #219457 Submission: ORIG-1 Active Ingredients: MULTIBIC Company: FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP LLC Submission Status: Approval Submission Classification: Type 2 - New Active Ingredient Application Number: 219457
- 2d agoApproval of ANASTROZOLE, ANDA #078058 (Labeling)FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: ANASTROZOLE, ANDA #078058 Submission: SUPPL-16 Active Ingredients: ANASTROZOLE Company: TEVA PHARMS Submission Status: Approval Submission Classification: Labeling Application Number: 078058
- 2d agoApproval of PRUCALOPRIDE SUCCINATE, ANDA #218492 (Labeling)FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: PRUCALOPRIDE SUCCINATE, ANDA #218492 Submission: SUPPL-3 Active Ingredients: PRUCALOPRIDE SUCCINATE Company: NOVITIUM PHARMA Submission Status: Approval Submission Classification: Labeling Application Number: 218492
- 2d agoApproval of KANJINTI, BLA #761073FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: KANJINTI, BLA #761073 Submission: SUPPL-12 Active Ingredients: TRASTUZUMAB-ANNS Company: AMGEN INC Submission Status: Approval Application Number: 761073
- 2d agoApproval of TOFACITINIB CITRATE, ANDA #220458FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: TOFACITINIB CITRATE, ANDA #220458 Submission: ORIG-2 Active Ingredients: TOFACITINIB CITRATE Company: APOTEX Submission Status: Approval Application Number: 220458
- 2d agoApproval of ZOLPIMIST, NDA #022196 (Labeling)FDA Approved DrugsApproval Date: 11/09/2026 Drug Name: ZOLPIMIST, NDA #022196 Submission: SUPPL-13 Active Ingredients: ZOLPIDEM TARTRATE Company: AYTU Submission Status: Approval Submission Classification: Labeling Application Number: 022196
- 5d agoApproval of MIRALAX, NDA #022015 (Labeling)FDA Approved DrugsApproval Date: 11/06/2026 Drug Name: MIRALAX, NDA #022015 Submission: SUPPL-51 Active Ingredients: POLYETHYLENE GLYCOL 3350 Company: BAYER HEALTHCARE LLC Submission Status: Approval Submission Classification: Labeling Application Number: 022015
- 5d agoApproval of HYMPAVZI, BLA #761369FDA Approved DrugsApproval Date: 11/06/2026 Drug Name: HYMPAVZI, BLA #761369 Submission: SUPPL-8 Active Ingredients: MARSTACIMAB-HNCQ Company: PFIZER INC Submission Status: Approval Application Number: 761369
- 5d agoApproval of ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, NDA #021704 (Labeling)FDA Approved DrugsApproval Date: 11/06/2026 Drug Name: ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, NDA #021704 Submission: SUPPL-27 Active Ingredients: FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Company: CHATTEM SANOFI Submission Status: Approval Submission Classification: Labeling Application Number: 021704
- 5d agoApproval of TOFACITINIB CITRATE, ANDA #220972FDA Approved DrugsApproval Date: 11/06/2026 Drug Name: TOFACITINIB CITRATE, ANDA #220972 Submission: ORIG-2 Active Ingredients: TOFACITINIB CITRATE Company: SCIEGEN PHARMS Submission Status: Approval Application Number: 220972
- 5d agoApproval of BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, ANDA #217589FDA Approved DrugsApproval Date: 11/06/2026 Drug Name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, ANDA #217589 Submission: ORIG-1 Active Ingredients: BRIMONIDINE TARTRATE; TIMOLOL MALEATE Company: MICRO LABS Submission Status: Approval Application Number: 217589
- 5d agoApproval of BRIVARACETAM, ANDA #220832FDA Approved DrugsApproval Date: 11/06/2026 Drug Name: BRIVARACETAM, ANDA #220832 Submission: ORIG-1 Active Ingredients: BRIVARACETAM Company: APPCO Submission Status: Approval Application Number: 220832
- 5d agoApproval of TAFAMIDIS MEGLUMINE, ANDA #218617FDA Approved DrugsApproval Date: 11/06/2026 Drug Name: TAFAMIDIS MEGLUMINE, ANDA #218617 Submission: ORIG-1 Active Ingredients: TAFAMIDIS MEGLUMINE Company: AUROBINDO PHARMA LTD Submission Status: Approval Application Number: 218617
- 5d agoApproval of VENLAFAXINE HYDROCHLORIDE, ANDA #220619FDA Approved DrugsApproval Date: 11/06/2026 Drug Name: VENLAFAXINE HYDROCHLORIDE, ANDA #220619 Submission: ORIG-1 Active Ingredients: VENLAFAXINE HYDROCHLORIDE Company: YICHANG HUMANWELL Submission Status: Approval Application Number: 220619
- 5d agoApproval of WELIREG, NDA #215383 (Labeling)FDA Approved DrugsApproval Date: 11/06/2026 Drug Name: WELIREG, NDA #215383 Submission: SUPPL-18 Active Ingredients: BELZUTIFAN Company: MERCK SHARP DOHME Submission Status: Approval Submission Classification: Labeling Application Number: 215383
- 6d agoApproval of FENOFIBRATE, ANDA #210476 (Labeling)FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: FENOFIBRATE, ANDA #210476 Submission: SUPPL-14 Active Ingredients: FENOFIBRATE Company: ALEMBIC Submission Status: Approval Submission Classification: Labeling Application Number: 210476
- 6d agoApproval of LINAGLIPTIN, ANDA #208448 (Labeling)FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: LINAGLIPTIN, ANDA #208448 Submission: SUPPL-1 Active Ingredients: LINAGLIPTIN Company: ZYDUS PHARMS Submission Status: Approval Submission Classification: Labeling Application Number: 208448
- 6d agoApproval of DIVALPROEX SODIUM, ANDA #079163 (Labeling)FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: DIVALPROEX SODIUM, ANDA #079163 Submission: SUPPL-34 Active Ingredients: DIVALPROEX SODIUM Company: UNICHEM LABS LTD Submission Status: Approval Submission Classification: Labeling Application Number: 079163
- 6d agoApproval of ATOVAQUONE, ANDA #210510 (Labeling)FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: ATOVAQUONE, ANDA #210510 Submission: SUPPL-14 Active Ingredients: ATOVAQUONE Company: ABHAI LLC Submission Status: Approval Submission Classification: Labeling Application Number: 210510
- 6d agoApproval of AMJEVITA, BLA #761024FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: AMJEVITA, BLA #761024 Submission: SUPPL-27 Active Ingredients: ADALIMUMAB-ATTO Company: AMGEN INC Submission Status: Approval Application Number: 761024
- 6d agoApproval of AMITRIPTYLINE HYDROCHLORIDE, ANDA #219639FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: AMITRIPTYLINE HYDROCHLORIDE, ANDA #219639 Submission: ORIG-1 Active Ingredients: AMITRIPTYLINE HYDROCHLORIDE Company: CMP DEV LLC Submission Status: Approval Application Number: 219639
- 6d agoApproval of ELTROMBOPAG OLAMINE, ANDA #221019FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: ELTROMBOPAG OLAMINE, ANDA #221019 Submission: ORIG-1 Active Ingredients: ELTROMBOPAG OLAMINE Company: CHANGZHOU PHARM Submission Status: Approval Application Number: 221019
- 6d agoApproval of SPS, ANDA #087859 (Labeling)FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: SPS, ANDA #087859 Submission: SUPPL-29 Active Ingredients: SODIUM POLYSTYRENE SULFONATE Company: CMP PHARMA INC Submission Status: Approval Submission Classification: Labeling Application Number: 087859
- 6d agoApproval of DIVALPROEX SODIUM, ANDA #079163 (Labeling)FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: DIVALPROEX SODIUM, ANDA #079163 Submission: SUPPL-39 Active Ingredients: DIVALPROEX SODIUM Company: UNICHEM LABS LTD Submission Status: Approval Submission Classification: Labeling Application Number: 079163
- 6d agoApproval of RYBREVANT FASPRO, BLA #761433FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: RYBREVANT FASPRO, BLA #761433 Submission: SUPPL-2 Active Ingredients: AMIVANTAMAB AND HYALURONIDASE-LPUJ Company: JANSSEN BIOTECH Submission Status: Approval Application Number: 761433
- 6d agoApproval of DIVALPROEX SODIUM, ANDA #079163 (Labeling)FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: DIVALPROEX SODIUM, ANDA #079163 Submission: SUPPL-36 Active Ingredients: DIVALPROEX SODIUM Company: UNICHEM LABS LTD Submission Status: Approval Submission Classification: Labeling Application Number: 079163
- 6d agoTentative Approval of PHENYLEPHRINE HYDROCHLORIDE IN SODIUM CHLORIDE, NDA #215783 (Type 5 - New Formulation or New Manufacturer)FDA Approved DrugsApproval Date: 11/05/2026 Drug Name: PHENYLEPHRINE HYDROCHLORIDE IN SODIUM CHLORIDE, NDA #215783 Submission: ORIG-1 Active Ingredients: PHENYLEPHRINE HYDROCHLORIDE IN SODIUM CHLORIDE Company: INFORLIFE Submission Status: Tentative Approval Submission Classification: Type 5 - New Formulation or New Manufacturer Application Number: 215783
- 1w agoApproval of ORGOVYX, NDA #214621 (Labeling)FDA Approved DrugsApproval Date: 11/04/2026 Drug Name: ORGOVYX, NDA #214621 Submission: SUPPL-15 Active Ingredients: RELUGOLIX Company: SUMITOMO PHARMA AM Submission Status: Approval Submission Classification: Labeling Application Number: 214621
- 1w agoApproval of ZYNLONTA, BLA #761196FDA Approved DrugsApproval Date: 11/04/2026 Drug Name: ZYNLONTA, BLA #761196 Submission: SUPPL-15 Active Ingredients: LONCASTUXIMAB TESIRINE-LPYL Company: ADC Therapeutics SA Submission Status: Approval Application Number: 761196
- 1w agoApproval of EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, ANDA #203442 (Labeling)FDA Approved DrugsApproval Date: 11/04/2026 Drug Name: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, ANDA #203442 Submission: SUPPL-12 Active Ingredients: EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Company: MACLEODS PHARMS Submission Status: Approval Submission Classification: Labeling Application Number: 203442
- 1w agoApproval of RELEUKO, BLA #761082FDA Approved DrugsApproval Date: 11/04/2026 Drug Name: RELEUKO, BLA #761082 Submission: SUPPL-5 Active Ingredients: FILGRASTIM-AYOW Company: KASHIV BIOSCIENCES LLC Submission Status: Approval Application Number: 761082
- 1w agoApproval of IRBESARTAN, ANDA #203071 (Labeling)FDA Approved DrugsApproval Date: 11/04/2026 Drug Name: IRBESARTAN, ANDA #203071 Submission: SUPPL-12 Active Ingredients: IRBESARTAN Company: PRINSTON INC Submission Status: Approval Submission Classification: Labeling Application Number: 203071
- 1w agoApproval of BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, ANDA #217922 (Labeling)FDA Approved DrugsApproval Date: 11/03/2026 Drug Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, ANDA #217922 Submission: SUPPL-3 Active Ingredients: BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE Company: AUROBINDO PHARMA LTD Submission Status: Approval Submission Classification: Labeling Application Number: 217922
- 1w agoApproval of ISOTRETINOIN, ANDA #216097 (Labeling)FDA Approved DrugsApproval Date: 11/03/2026 Drug Name: ISOTRETINOIN, ANDA #216097 Submission: SUPPL-2 Active Ingredients: ISOTRETINOIN Company: AMNEAL PHARMS NY Submission Status: Approval Submission Classification: Labeling Application Number: 216097
- 1w agoApproval of GUAIFENESIN, ANDA #207342 (Labeling)FDA Approved DrugsApproval Date: 11/03/2026 Drug Name: GUAIFENESIN, ANDA #207342 Submission: SUPPL-17 Active Ingredients: GUAIFENESIN Company: AMNEAL PHARMS Submission Status: Approval Submission Classification: Labeling Application Number: 207342
- 1w agoApproval of BOMYNTRA, BLA #761398FDA Approved DrugsApproval Date: 11/03/2026 Drug Name: BOMYNTRA, BLA #761398 Submission: SUPPL-3 Active Ingredients: DENOSUMAB-BNHT Company: FRESENIUS KABI USA LLC Submission Status: Approval Application Number: 761398
- 1w agoApproval of FLUTICASONE PROPIONATE, ANDA #209917FDA Approved DrugsApproval Date: 11/03/2026 Drug Name: FLUTICASONE PROPIONATE, ANDA #209917 Submission: ORIG-1 Active Ingredients: FLUTICASONE PROPIONATE Company: TEVA PHARMS USA INC Submission Status: Approval Application Number: 209917
- 1w agoApproval of FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, ANDA #076298 (Labeling)FDA Approved DrugsApproval Date: 11/03/2026 Drug Name: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, ANDA #076298 Submission: SUPPL-4 Active Ingredients: FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Company: IMPAX PHARMS Submission Status: Approval Submission Classification: Labeling Application Number: 076298
- 1w agoApproval of CONEXXENCE, BLA #761398FDA Approved DrugsApproval Date: 11/03/2026 Drug Name: CONEXXENCE, BLA #761398 Submission: SUPPL-3 Active Ingredients: DENOSUMAB-BNHT Company: FRESENIUS KABI USA LLC Submission Status: Approval Application Number: 761398
- 1w agoApproval of ISOTRETINOIN, ANDA #218194 (Labeling)FDA Approved DrugsApproval Date: 11/03/2026 Drug Name: ISOTRETINOIN, ANDA #218194 Submission: SUPPL-5 Active Ingredients: ISOTRETINOIN Company: AUROBINDO PHARMA Submission Status: Approval Submission Classification: Labeling Application Number: 218194
- 1w agoApproval of ISOTRETINOIN, ANDA #216097 (Labeling)FDA Approved DrugsApproval Date: 11/03/2026 Drug Name: ISOTRETINOIN, ANDA #216097 Submission: SUPPL-4 Active Ingredients: ISOTRETINOIN Company: AMNEAL PHARMS NY Submission Status: Approval Submission Classification: Labeling Application Number: 216097
- 1w agoApproval of GUAIFENESIN, ANDA #213420 (Labeling)FDA Approved DrugsApproval Date: 11/03/2026 Drug Name: GUAIFENESIN, ANDA #213420 Submission: SUPPL-10 Active Ingredients: GUAIFENESIN Company: GRANULES Submission Status: Approval Submission Classification: Labeling Application Number: 213420