FDA approves PSEUDOEPHEDRINE HYDROCHLORIDE from AUROBINDO PHARMA LTD FDA Approval Dec. 31, 2025, 13:45 UTC 36 0 comments Final approval of ANDA #ANDA #218854 for PSEUDOEPHEDRINE HYDROCHLORIDE. Decision date: 12/29/2025 Comment Full text
FDA updates labeling for NALBUPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Labeling changes approved for SOMERSET THERAPS LLC. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ORLADEYO FDA Approval Dec. 31, 2025, 13:45 UTC 41 0 comments Labeling changes approved for BIOCRYST. Active ingredient: BEROTRALSTAT DIHYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 39 0 comments Labeling changes approved for HIKMA. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from JIANGSU HANSOH PHARM FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Tentative approval of ANDA #ANDA #216119 for DAPAGLIFLOZIN. Decision date: 12/23/2025 Comment Full text
FDA approves manufacturing change for MIRABEGRON FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Manufacturing process update for LUPIN LTD. Submission: SUPPL-9. Decision date: 12/29/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 36 0 comments Labeling changes approved for SOMERSET THERAPS LLC. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA grants tentative approval for NINTEDANIB from GLENMARK PHARMS LTD FDA Approval Dec. 31, 2025, 13:45 UTC 39 0 comments Tentative approval of ANDA #ANDA #212555 for NINTEDANIB ESYLATE. Decision date: 12/23/2025 Comment Full text
FDA approves EPOPROSTENOL SODIUM from GLAND FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Final approval of ANDA #ANDA #219237 for EPOPROSTENOL SODIUM. Decision date: 12/29/2025 Comment Full text
FDA updates labeling for ARYNTA FDA Approval Dec. 31, 2025, 13:45 UTC 45 0 comments Labeling changes approved for AZURITY. Active ingredient: LISDEXAMFETAMINE DIMESYLATE. Decision date: 12/22/2025 Comment Full text