FDA grants tentative approval for MIRABEGRON from SUNSHINE LAKE PHARMA CO LTD FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Tentative approval of ANDA #ANDA #216757 for MIRABEGRON. Decision date: 12/10/2025 Comment Full text
FDA regulatory update for RYSTIGGO FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Administrative update #SUPPL-7 for UCB INC. Status: Approval. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Labeling changes approved for APOTEX. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA approves NOREPINEPHRINE BITARTRATE from MSN FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Final approval of ANDA #ANDA #218595 for NOREPINEPHRINE BITARTRATE. Decision date: 12/11/2025 Comment Full text
FDA expands indications for ADDYI FDA Approval Dec. 31, 2025, 13:45 UTC 34 0 comments SPROUT PHARMS receives approval for new indications. Submission: SUPPL-13. Decision date: 12/13/2025 Comment Full text
FDA regulatory update for ACTEMRA FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Administrative update #SUPPL-147 for GENENTECH. Status: Approval. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for ACTAVIS ELIZABETH. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/12/2025 Comment Full text
FDA regulatory update for ROLVEDON FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Administrative update #SUPPL-11 for SPECTRUM PHARMS. Status: Approval. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for SUN PHARM INDS INC. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Labeling changes approved for WATSON LABS. Active ingredient: NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text