FDA grants tentative approval for BRIVARACETAM from MSN LABORATORIES PRIVATE LTD FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Tentative approval of ANDA #ANDA #214924 for BRIVARACETAM. Decision date: 12/01/2025 Comment Full text
FDA grants tentative approval for BRIVARACETAM from MSN LABS PVT LTD FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Tentative approval of ANDA #ANDA #214922 for BRIVARACETAM. Decision date: 12/01/2025 Comment Full text
FDA approves PROPOFOL from NANJING KING FRIEND FDA Approval Dec. 31, 2025, 13:45 UTC 17 0 comments Final approval of ANDA #ANDA #217945 for PROPOFOL. Decision date: 12/02/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for ELITE LABS INC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/02/2025 Comment Full text
FDA regulatory update for SELARSDI FDA Approval Dec. 31, 2025, 13:45 UTC 10 0 comments Administrative update #SUPPL-13 for ALVOTECH USA INC. Status: Approval. Decision date: 12/01/2025 Comment Full text
FDA updates labeling for OLANZAPINE FDA Approval Dec. 31, 2025, 13:45 UTC 19 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 16 0 comments Tentative approval of ANDA #ANDA #212555 for NINTEDANIB ESYLATE. Decision date: 12/23/2025 Comment Full text
FDA approves GLYCOPYRROLATE from BIONPHARMA FDA Approval Dec. 30, 2025, 09:55 UTC 19 0 comments Final approval of ANDA #ANDA #220062 for GLYCOPYRROLATE. Decision date: 12/23/2025 Comment Full text
FDA approves METHYLENE BLUE from CHENGDU SHUODE FDA Approval Dec. 30, 2025, 09:55 UTC 16 0 comments Final approval of ANDA #ANDA #219550 for METHYLENE BLUE. Decision date: 12/23/2025 Comment Full text
FDA approves POTASSIUM CHLORIDE from QUAGEN FDA Approval Dec. 30, 2025, 09:55 UTC 21 0 comments Final approval of ANDA #ANDA #215716 for POTASSIUM CHLORIDE. Decision date: 12/22/2025 Comment Full text