FDA updates labeling for REZZAYO FDA Approval Dec. 31, 2025, 13:45 UTC 3 0 comments Labeling changes approved for MUNDIPHARMA. Active ingredient: REZAFUNGIN ACETATE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 4 0 comments Labeling changes approved for RISING. Active ingredient: ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for CABERGOLINE FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for INGENUS PHARMS LLC. Active ingredient: CABERGOLINE. Decision date: 12/11/2025 Comment Full text
FDA approves manufacturing change for NISOLDIPINE FDA Approval Dec. 31, 2025, 13:45 UTC 4 0 comments Manufacturing process update for AMTA. Submission: SUPPL-2. Decision date: 12/12/2025 Comment Full text
FDA regulatory update for ACTEMRA FDA Approval Dec. 31, 2025, 13:45 UTC 3 0 comments Administrative update #SUPPL-147 for GENENTECH. Status: Approval. Decision date: 12/10/2025 Comment Full text
FDA expands indications for ADDYI FDA Approval Dec. 31, 2025, 13:45 UTC 9 0 comments SPROUT PHARMS receives approval for new indications. Submission: SUPPL-13. Decision date: 12/13/2025 Comment Full text
FDA updates labeling for XTANDI FDA Approval Dec. 31, 2025, 13:45 UTC 1 0 comments Labeling changes approved for ASTELLAS. Active ingredient: ENZALUTAMIDE. Decision date: 12/11/2025 Comment Full text
FDA updates labeling for PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 4 0 comments Labeling changes approved for PHARMOBEDIENT. Active ingredient: CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA approves NOREPINEPHRINE BITARTRATE from MSN FDA Approval Dec. 31, 2025, 13:45 UTC 2 0 comments Final approval of ANDA #ANDA #218595 for NOREPINEPHRINE BITARTRATE. Decision date: 12/11/2025 Comment Full text
FDA grants tentative approval for MIRABEGRON from SUNSHINE LAKE PHARMA CO LTD FDA Approval Dec. 31, 2025, 13:45 UTC 1 0 comments Tentative approval of ANDA #ANDA #216757 for MIRABEGRON. Decision date: 12/10/2025 Comment Full text