FDA updates labeling for LOSARTAN POTASSIUM FDA Approval Dec. 31, 2025, 13:45 UTC 17 0 comments Labeling changes approved for ALEMBIC PHARMS LTD. Active ingredient: LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE from ASCENT PHARMS INC FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Final approval of ANDA #ANDA #219401 for BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/18/2025 Comment Full text
FDA approves manufacturing change for NICARDIPINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Manufacturing process update for CHENGDU SHUODE. Submission: SUPPL-1. Decision date: 12/18/2025 Comment Full text
FDA approves TENOFOVIR DISOPROXIL FUMARATE from MICRO LABS FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Final approval of ANDA #ANDA #206157 for TENOFOVIR DISOPROXIL FUMARATE. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for ZINGO FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Labeling changes approved for POWDER PHARMS. Active ingredient: LIDOCAINE HYDROCHLORIDE. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for WAINUA (AUTOINJECTOR) FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for ASTRAZENECA AB. Active ingredient: EPLONTERSEN SODIUM. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND IBUPROFEN FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Labeling changes approved for GRANULES. Active ingredient: ACETAMINOPHEN; IBUPROFEN. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for FLONASE ALLERGY RELIEF FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for HALEON US HOLDINGS. Active ingredient: FLUTICASONE PROPIONATE. Decision date: 12/19/2025 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from TEVA PHARMS USA INC FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Tentative approval of ANDA #ANDA #211541 for DAPAGLIFLOZIN. Decision date: 12/18/2025 Comment Full text
FDA approves TRAVOPROST from ALEMBIC FDA Approval Dec. 31, 2025, 13:45 UTC 19 0 comments Final approval of ANDA #ANDA #214687 for TRAVOPROST. Decision date: 12/17/2025 Comment Full text