FDA updates labeling for ILLUCCIX FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Labeling changes approved for TELIX. Active ingredient: GALLIUM GA-68 GOZETOTIDE. Decision date: 12/05/2025 Comment Full text
FDA approves ACETAMINOPHEN from CAPLIN FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Final approval of ANDA #ANDA #219096 for ACETAMINOPHEN. Decision date: 12/05/2025 Comment Full text
FDA updates labeling for IMITREX FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN. Decision date: 12/09/2025 Comment Full text
FDA approves SITAGLIPTIN AND METFORMIN HYDROCHLORIDE from SANDOZ FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Final approval of ANDA #ANDA #202388 for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE. Decision date: 12/02/2025 Comment Full text
FDA grants tentative approval for BRIVARACETAM from MSN LABS PVT LTD FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Tentative approval of ANDA #ANDA #214922 for BRIVARACETAM. Decision date: 12/01/2025 Comment Full text
FDA approves manufacturing change for CEFAZOLIN SODIUM FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Manufacturing process update for HIKMA FARMACEUTICA. Submission: SUPPL-34. Decision date: 12/01/2025 Comment Full text
FDA updates labeling for TOPIRAMATE FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for GLENMARK PHARMS LTD. Active ingredient: TOPIRAMATE. Decision date: 12/04/2025 Comment Full text
FDA grants tentative approval for SUGAMMADEX from MANKIND PHARMA FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Tentative approval of ANDA #ANDA #214230 for SUGAMMADEX. Decision date: 12/01/2025 Comment Full text
FDA updates labeling for RIFADIN FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for SANOFI AVENTIS US. Active ingredient: RIFAMPIN. Decision date: 12/05/2025 Comment Full text
FDA grants tentative approval for CLADRIBINE from HOPEWELL PHARMA VENTURES, INC. FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Tentative approval of ANDA #ANDA #215547 for CLADRIBINE. Decision date: 12/04/2025 Comment Full text