FDA approves METHYLENE BLUE from CHENGDU SHUODE FDA Approval Dec. 30, 2025, 09:55 UTC 25 0 comments Final approval of ANDA #ANDA #219550 for METHYLENE BLUE. Decision date: 12/23/2025 Comment Full text
FDA approves PSEUDOEPHEDRINE HYDROCHLORIDE from AUROBINDO PHARMA LTD FDA Approval Dec. 30, 2025, 09:55 UTC 32 0 comments Final approval of ANDA #ANDA #218854 for PSEUDOEPHEDRINE HYDROCHLORIDE. Decision date: 12/29/2025 Comment Full text
FDA updates labeling for LOSARTAN POTASSIUM FDA Approval Dec. 30, 2025, 09:55 UTC 29 0 comments Labeling changes approved for ALEMBIC PHARMS LTD. Active ingredient: LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
FDA approves NITROGLYCERIN from SOLARIS PHARMA CORP FDA Approval Dec. 30, 2025, 09:55 UTC 26 0 comments Final approval of ANDA #ANDA #218756 for NITROGLYCERIN. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for LOSARTAN POTASSIUM FDA Approval Dec. 30, 2025, 09:55 UTC 26 0 comments Labeling changes approved for HETERO LABS LTD V. Active ingredient: LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE from ASCENT PHARMS INC FDA Approval Dec. 30, 2025, 09:55 UTC 24 0 comments Final approval of ANDA #ANDA #219401 for BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/18/2025 Comment Full text
FDA approves DECITABINE from RELIANCE LIFE SCI FDA Approval Dec. 30, 2025, 09:55 UTC 36 0 comments Final approval of ANDA #ANDA #217814 for DECITABINE. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for YONDELIS FDA Approval Dec. 24, 2025, 09:48 UTC 54 0 comments Labeling changes approved for JANSSEN PRODS. Active ingredient: TRABECTEDIN. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 24, 2025, 09:48 UTC 75 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 BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 24, 2025, 09:48 UTC 54 0 comments Labeling changes approved for HIKMA. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text