FDA approves GLYCOPYRROLATE from BIONPHARMA FDA Approval Dec. 30, 2025, 09:55 UTC 25 0 comments Final approval of ANDA #ANDA #220062 for GLYCOPYRROLATE. Decision date: 12/23/2025 Comment Full text
FDA grants tentative approval for NINTEDANIB from GLENMARK PHARMS LTD FDA Approval Dec. 30, 2025, 09:55 UTC 23 0 comments Tentative approval of ANDA #ANDA #212555 for NINTEDANIB ESYLATE. Decision date: 12/23/2025 Comment Full text
FDA approves DECITABINE from RELIANCE LIFE SCI FDA Approval Dec. 30, 2025, 09:55 UTC 34 0 comments Final approval of ANDA #ANDA #217814 for DECITABINE. Decision date: 12/19/2025 Comment Full text
FDA approves NITROGLYCERIN from SOLARIS PHARMA CORP FDA Approval Dec. 30, 2025, 09:55 UTC 25 0 comments Final approval of ANDA #ANDA #218756 for NITROGLYCERIN. Decision date: 12/18/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE from ASCENT PHARMS INC FDA Approval Dec. 30, 2025, 09:55 UTC 23 0 comments Final approval of ANDA #ANDA #219401 for BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for LOSARTAN POTASSIUM FDA Approval Dec. 30, 2025, 09:55 UTC 25 0 comments Labeling changes approved for HETERO LABS LTD V. Active ingredient: LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
FDA updates labeling for LOSARTAN POTASSIUM FDA Approval Dec. 30, 2025, 09:55 UTC 28 0 comments Labeling changes approved for ALEMBIC PHARMS LTD. Active ingredient: LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 24, 2025, 09:48 UTC 72 0 comments Labeling changes approved for SOMERSET THERAPS LLC. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for YONDELIS FDA Approval Dec. 24, 2025, 09:48 UTC 51 0 comments Labeling changes approved for JANSSEN PRODS. Active ingredient: TRABECTEDIN. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 24, 2025, 09:48 UTC 53 0 comments Labeling changes approved for PHARMOBEDIENT. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text