FDA updates labeling for IMITREX FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for GLAXOSMITHKLINE. Active ingredient: SUMATRIPTAN SUCCINATE. Decision date: 12/09/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Labeling changes approved for ANI PHARMS. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/09/2025 Comment Full text
FDA grants tentative approval for LINAGLIPTIN from APOTEX FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Tentative approval of ANDA #ANDA #218552 for LINAGLIPTIN. Decision date: 12/08/2025 Comment Full text
FDA updates labeling for EPLERENONE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for RISING. Active ingredient: EPLERENONE. Decision date: 12/04/2025 Comment Full text
FDA approves MACITENTAN from MYLAN FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Final approval of ANDA #ANDA #211161 for MACITENTAN. Decision date: 12/03/2025 Comment Full text
FDA updates labeling for RIFADIN FDA Approval Dec. 31, 2025, 13:45 UTC 29 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 30 0 comments Tentative approval of ANDA #ANDA #215547 for CLADRIBINE. Decision date: 12/04/2025 Comment Full text
FDA updates labeling for ERTUGLIFLOZIN FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for AUROBINDO PHARMA LTD. Active ingredient: ERTUGLIFLOZIN. Decision date: 12/03/2025 Comment Full text
FDA regulatory update for TEVIMBRA FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Administrative update #SUPPL-15 for BEIGENE. Status: Approval. Decision date: 12/02/2025 Comment Full text
FDA updates labeling for OLANZAPINE FDA Approval Dec. 31, 2025, 13:45 UTC 18 0 comments Labeling changes approved for TORRENT. Active ingredient: OLANZAPINE. Decision date: 12/03/2025 Comment Full text