FDA grants tentative approval for RIFAXIMIN from CIPLA LTD FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Tentative approval of ANDA #ANDA #219570 for RIFAXIMIN. Decision date: 12/08/2025 Comment Full text
FDA approves LINEZOLID from CAPLIN FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Final approval of ANDA #ANDA #219558 for LINEZOLID. Decision date: 12/08/2025 Comment Full text
FDA regulatory update for ETICOVO FDA Approval Dec. 31, 2025, 13:45 UTC 18 0 comments Administrative update #SUPPL-6 for SAMSUNG BIOEPIS CO LTD. Status: Approval. Decision date: 12/05/2025 Comment Full text
FDA updates labeling for IMITREX FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN SUCCINATE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for IMITREX FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN SUCCINATE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for IMITREX FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 18 0 comments Labeling changes approved for HIKMA. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/09/2025 Comment Full text
FDA regulatory update for WINREVAIR FDA Approval Dec. 31, 2025, 13:45 UTC 19 0 comments Administrative update #SUPPL-8 for MERCK SHARP DOHME. Status: Approval. Decision date: 12/08/2025 Comment Full text
FDA updates labeling for RIFATER FDA Approval Dec. 31, 2025, 13:45 UTC 14 0 comments Labeling changes approved for SANOFI AVENTIS US. Active ingredient: ISONIAZID; PYRAZINAMIDE; RIFAMPIN. Decision date: 12/05/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 15 0 comments Labeling changes approved for PH HEALTH. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/05/2025 Comment Full text