FDA updates labeling for YONDELIS FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Labeling changes approved for JANSSEN PRODS. Active ingredient: TRABECTEDIN. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 32 0 comments Labeling changes approved for QUAGEN. Active ingredient: CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA regulatory update for POMALIDOMIDE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Administrative update #SUPPL-2 for HETERO LABS LTD V. Status: Approval. Decision date: 12/29/2025 Comment Full text
FDA approves EPOPROSTENOL SODIUM from GLAND FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Final approval of ANDA #ANDA #219237 for EPOPROSTENOL SODIUM. Decision date: 12/29/2025 Comment Full text
FDA grants tentative approval for NINTEDANIB from GLENMARK PHARMS LTD FDA Approval Dec. 31, 2025, 13:45 UTC 40 0 comments Tentative approval of ANDA #ANDA #212555 for NINTEDANIB ESYLATE. Decision date: 12/23/2025 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from JIANGSU HANSOH PHARM FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Tentative approval of ANDA #ANDA #216119 for DAPAGLIFLOZIN. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Labeling changes approved for GRANULES. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 36 0 comments Labeling changes approved for SOMERSET THERAPS LLC. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OLINVYK FDA Approval Dec. 31, 2025, 13:45 UTC 48 0 comments Labeling changes approved for TREVENA. Active ingredient: OLICERIDINE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 41 0 comments Labeling changes approved for ASCENT PHARMS INC. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text