FDA updates labeling for ERTUGLIFLOZIN FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Labeling changes approved for AUROBINDO PHARMA LTD. Active ingredient: ERTUGLIFLOZIN. Decision date: 12/03/2025 Comment Full text
FDA approves PROPOFOL from NANJING KING FRIEND FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Final approval of ANDA #ANDA #217945 for PROPOFOL. Decision date: 12/02/2025 Comment Full text
FDA updates labeling for TOPIRAMATE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for GLENMARK PHARMS LTD. Active ingredient: TOPIRAMATE. Decision date: 12/04/2025 Comment Full text
FDA updates labeling for RIFADIN FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for SANOFI AVENTIS US. Active ingredient: RIFAMPIN. Decision date: 12/05/2025 Comment Full text
FDA approves ALBUTEROL SULFATE from AMNEAL IRELAND LTD FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Final approval of ANDA #ANDA #211600 for ALBUTEROL SULFATE. Decision date: 12/01/2025 Comment Full text
FDA updates labeling for OLANZAPINE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for TORRENT PHARMS LTD. Active ingredient: OLANZAPINE. Decision date: 12/02/2025 Comment Full text
FDA grants tentative approval for NINTEDANIB from GLENMARK PHARMS LTD FDA Approval Dec. 30, 2025, 09:55 UTC 23 0 comments Tentative approval of ANDA #ANDA #212555 for NINTEDANIB ESYLATE. Decision date: 12/23/2025 Comment Full text
FDA approves METHYLENE BLUE from CHENGDU SHUODE FDA Approval Dec. 30, 2025, 09:55 UTC 24 0 comments Final approval of ANDA #ANDA #219550 for METHYLENE BLUE. Decision date: 12/23/2025 Comment Full text
FDA approves GLYCOPYRROLATE from BIONPHARMA FDA Approval Dec. 30, 2025, 09:55 UTC 25 0 comments Final approval of ANDA #ANDA #220062 for GLYCOPYRROLATE. Decision date: 12/23/2025 Comment Full text
FDA approves PSEUDOEPHEDRINE HYDROCHLORIDE from AUROBINDO PHARMA LTD FDA Approval Dec. 30, 2025, 09:55 UTC 31 0 comments Final approval of ANDA #ANDA #218854 for PSEUDOEPHEDRINE HYDROCHLORIDE. Decision date: 12/29/2025 Comment Full text