FDA updates labeling for CLOMIPHENE CITRATE FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Labeling changes approved for COSETTE. Active ingredient: CLOMIPHENE CITRATE. Decision date: 12/18/2025 Comment Full text
FDA approves RYBREVANT FASPRO from JANSSEN BIOTECH FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Final approval of BLA #BLA #761433 for AMIVANTAMAB AND HYALURONIDASE-LPUJ. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for CLARISCAN FDA Approval Dec. 31, 2025, 13:45 UTC 17 0 comments Labeling changes approved for GE HEALTHCARE. Active ingredient: GADOTERATE MEGLUMINE. Decision date: 12/15/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE from ASCENT PHARMS INC FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Final approval of ANDA #ANDA #219401 for BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for ZINGO FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for POWDER PHARMS. Active ingredient: LIDOCAINE HYDROCHLORIDE. Decision date: 12/19/2025 Comment Full text
FDA approves manufacturing change for NICARDIPINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Manufacturing process update for CHENGDU SHUODE. Submission: SUPPL-1. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for FLONASE ALLERGY RELIEF FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for HALEON US HOLDINGS. Active ingredient: FLUTICASONE PROPIONATE. Decision date: 12/19/2025 Comment Full text
FDA approves NITROGLYCERIN from SOLARIS PHARMA CORP FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Final approval of ANDA #ANDA #218756 for NITROGLYCERIN. Decision date: 12/18/2025 Comment Full text
FDA approves HALOPERIDOL from CREEKWOOD PHARMS FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Final approval of ANDA #ANDA #218162 for HALOPERIDOL. Decision date: 12/18/2025 Comment Full text
FDA expands indications for VRAYLAR FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments ABBVIE receives approval for new indications. Submission: SUPPL-14. Decision date: 12/18/2025 Comment Full text