FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 24, 2025, 09:48 UTC 43 0 comments Labeling changes approved for AM REGENT. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 24, 2025, 09:48 UTC 43 0 comments Labeling changes approved for PHARMOBEDIENT. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA approves MUCINEX 12 HR COLD & FEVER MULTI-SYMPTOM from RB HLTH FDA Approval Dec. 23, 2025, 22:37 UTC 46 0 comments Final approval of NDA #NDA #217338 for DEXTROMETHORPHAN/GUAIFENESIN/NAPROXEN SODIUM. Decision date: 12/22/2025 Comment Full text
FDA approves BONCRESA from AMNEAL PHARMS LLC FDA Approval Dec. 23, 2025, 18:04 UTC 45 0 comments Final approval of BLA #BLA #761456 for DENOSUMAB. Decision date: 12/19/2025 Comment Full text
FDA approves OZILTUS from AMNEAL PHARMS LLC FDA Approval Dec. 23, 2025, 18:04 UTC 44 0 comments Final approval of BLA #BLA #761457 for DENOSUMAB. Decision date: 12/19/2025 Comment Full text
FDA approves WEGOVY from NOVO NORDISK INC FDA Approval Dec. 23, 2025, 13:40 UTC 40 0 comments Final approval of NDA #NDA #218316 for SEMAGLUTIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ZINGO FDA Approval Dec. 23, 2025, 09:48 UTC 24 0 comments Labeling changes approved for POWDER PHARMS. Active ingredient: LIDOCAINE HYDROCHLORIDE. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for PROSTIN VR PEDIATRIC FDA Approval Dec. 23, 2025, 09:48 UTC 21 0 comments Labeling changes approved for PFIZER. Active ingredient: ALPROSTADIL. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for VIVITROL FDA Approval Dec. 23, 2025, 09:48 UTC 21 0 comments Labeling changes approved for ALKERMES. Active ingredient: NALTREXONE. Decision date: 12/22/2025 Comment Full text
FDA approves TENOFOVIR DISOPROXIL FUMARATE from MICRO LABS FDA Approval Dec. 23, 2025, 09:48 UTC 19 0 comments Final approval of ANDA #ANDA #206157 for TENOFOVIR DISOPROXIL FUMARATE. Decision date: 12/18/2025 Comment Full text