FDA approves GLYCOPYRROLATE from BIONPHARMA FDA Approval Dec. 31, 2025, 13:45 UTC 7 0 comments Final approval of ANDA #ANDA #220062 for GLYCOPYRROLATE. Decision date: 12/23/2025 Comment Full text
FDA regulatory update for CABLIVI FDA Approval Dec. 31, 2025, 13:45 UTC 11 0 comments Administrative update #SUPPL-18 for ABLYNX NV. Status: Approval. Decision date: 12/23/2025 Comment Full text
FDA approves manufacturing change for MIRABEGRON FDA Approval Dec. 31, 2025, 13:45 UTC 7 0 comments Manufacturing process update for LUPIN LTD. Submission: SUPPL-9. Decision date: 12/29/2025 Comment Full text
FDA regulatory update for POMALIDOMIDE FDA Approval Dec. 31, 2025, 13:45 UTC 9 0 comments Administrative update #SUPPL-2 for HETERO LABS LTD V. Status: Approval. Decision date: 12/29/2025 Comment Full text
FDA updates labeling for ARYNTA FDA Approval Dec. 31, 2025, 13:45 UTC 14 0 comments Labeling changes approved for AZURITY. Active ingredient: LISDEXAMFETAMINE DIMESYLATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE AND IBUPROFEN FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for ACTAVIS ELIZABETH. Active ingredient: IBUPROFEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Labeling changes approved for MYLAN. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 12 0 comments Labeling changes approved for HIKMA. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA approves MUCINEX 12 HR COLD & FEVER MULTI-SYMPTOM from RB HLTH FDA Approval Dec. 31, 2025, 13:45 UTC 12 0 comments Final approval of NDA #NDA #217338 for DEXTROMETHORPHAN/GUAIFENESIN/NAPROXEN SODIUM. Decision date: 12/22/2025 Comment Full text
FDA approves WEGOVY from NOVO NORDISK INC FDA Approval Dec. 31, 2025, 13:45 UTC 12 0 comments Final approval of NDA #NDA #218316 for SEMAGLUTIDE. Decision date: 12/22/2025 Comment Full text