FDA approves NILOTINIB from TORRENT FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Final approval of ANDA #ANDA #218532 for NILOTINIB. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for CLOMIPHENE CITRATE FDA Approval Dec. 31, 2025, 13:45 UTC 36 0 comments Labeling changes approved for COSETTE. Active ingredient: CLOMIPHENE CITRATE. Decision date: 12/18/2025 Comment Full text
FDA regulatory update for ENHERTU FDA Approval Dec. 31, 2025, 13:45 UTC 51 0 comments Administrative update #SUPPL-38 for DAIICHI SANKYO. Status: Approval. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND IBUPROFEN FDA Approval Dec. 31, 2025, 13:45 UTC 47 0 comments Labeling changes approved for GRANULES. Active ingredient: ACETAMINOPHEN; IBUPROFEN. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for FLONASE SENSIMIST ALLERGY RELIEF FDA Approval Dec. 31, 2025, 13:45 UTC 46 0 comments Labeling changes approved for HALEON US HOLDINGS. Active ingredient: FLUTICASONE FUROATE. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for PRINSTON INC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for WAINUA (AUTOINJECTOR) FDA Approval Dec. 31, 2025, 13:45 UTC 48 0 comments Labeling changes approved for ASTRAZENECA AB. Active ingredient: EPLONTERSEN SODIUM. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for TESTOSTERONE FDA Approval Dec. 31, 2025, 13:45 UTC 44 0 comments Labeling changes approved for ENCUBE. Active ingredient: TESTOSTERONE. Decision date: 12/17/2025 Comment Full text
FDA approves NITROGLYCERIN from SOLARIS PHARMA CORP FDA Approval Dec. 31, 2025, 13:45 UTC 45 0 comments Final approval of ANDA #ANDA #218756 for NITROGLYCERIN. Decision date: 12/18/2025 Comment Full text
FDA approves EXDENSUR from GLAXOSMITHKLINE LLC FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Final approval of BLA #BLA #761458 for DEPEMOKIMAB-ULAA. Decision date: 12/16/2025 Comment Full text