FDA approves ORLADEYO from BIOCRYST FDA Approval Dec. 31, 2025, 13:45 UTC 37 0 comments Final approval of NDA #NDA #219776 for BEROTRALSTAT DIHYDROCHLORIDE. 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 31 0 comments Tentative approval of ANDA #ANDA #216757 for MIRABEGRON. Decision date: 12/10/2025 Comment Full text
FDA regulatory update for ADBRY FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Administrative update #SUPPL-19 for LEO PHARMA AS. Status: Approval. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 36 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 42 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 41 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 48 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 30 0 comments Labeling changes approved for ACTAVIS ELIZABETH. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 39 0 comments Labeling changes approved for SUN PHARM INDS INC. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE from AUROBINDO PHARMA LIMITED FDA Approval Dec. 31, 2025, 13:45 UTC 41 0 comments Tentative approval of ANDA #ANDA #211489 for DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE. Decision date: 12/10/2025 Comment Full text