FDA approves CARDAMYST from MILESTONE PHARMS USA FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Final approval of NDA #NDA #218571 for ETRIPAMIL. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Labeling changes approved for ACTAVIS LABS FL INC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/11/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE from SPECGX LLC FDA Approval Dec. 31, 2025, 13:45 UTC 13 0 comments Final approval of ANDA #ANDA #218473 for BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for REZZAYO FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for MUNDIPHARMA. Active ingredient: REZAFUNGIN ACETATE. Decision date: 12/10/2025 Comment Full text
FDA regulatory update for RYSTIGGO FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Administrative update #SUPPL-7 for UCB INC. Status: Approval. Decision date: 12/09/2025 Comment Full text
FDA regulatory update for ACTEMRA FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Administrative update #SUPPL-147 for GENENTECH. Status: Approval. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for THALLOUS CHLORIDE TL 201 FDA Approval Dec. 31, 2025, 13:45 UTC 11 0 comments Labeling changes approved for CURIUM. Active ingredient: THALLOUS CHLORIDE TL-201. Decision date: 12/10/2025 Comment Full text
FDA regulatory update for ACTEMRA FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Administrative update #SUPPL-59 for GENENTECH. Status: Approval. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for MOMETASONE FUROATE FDA Approval Dec. 31, 2025, 13:45 UTC 14 0 comments Labeling changes approved for FOUGERA PHARMS. Active ingredient: MOMETASONE FUROATE. Decision date: 12/10/2025 Comment Full text
FDA updates labeling for XTANDI FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Labeling changes approved for ASTELLAS. Active ingredient: ENZALUTAMIDE. Decision date: 12/11/2025 Comment Full text