FDA approves manufacturing change for NISOLDIPINE FDA Approval Dec. 31, 2025, 13:45 UTC 50 0 comments Manufacturing process update for AMTA. Submission: SUPPL-2. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 44 0 comments Labeling changes approved for TEVA. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/11/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 44 0 comments Labeling changes approved for ACTAVIS LABS FL INC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/11/2025 Comment Full text
FDA regulatory update for ACTEMRA FDA Approval Dec. 31, 2025, 13:45 UTC 45 0 comments Administrative update #SUPPL-59 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 38 0 comments Labeling changes approved for SUN PHARM. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/12/2025 Comment Full text
FDA approves LEROCHOL from LIB THERAPEUTICS, INC. FDA Approval Dec. 31, 2025, 13:45 UTC 45 0 comments Final approval of BLA #BLA #761427 for LERODALCIBEP-LIGA. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for DEPO-SUBQ PROVERA 104 FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Labeling changes approved for PFIZER. Active ingredient: MEDROXYPROGESTERONE ACETATE. Decision date: 12/12/2025 Comment Full text
FDA expands indications for AKEEGA FDA Approval Dec. 31, 2025, 13:45 UTC 37 0 comments JANSSEN BIOTECH receives approval for new indications. Submission: SUPPL-1. Decision date: 12/12/2025 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
FDA approves CARDAMYST from MILESTONE PHARMS USA FDA Approval Dec. 31, 2025, 13:45 UTC 40 0 comments Final approval of NDA #NDA #218571 for ETRIPAMIL. Decision date: 12/12/2025 Comment Full text