FDA updates labeling for LOSARTAN POTASSIUM FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for ALEMBIC PHARMS LTD. Active ingredient: LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
FDA approves TRAVOPROST from ALEMBIC FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Final approval of ANDA #ANDA #214687 for TRAVOPROST. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for TESTOSTERONE FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Labeling changes approved for ENCUBE. Active ingredient: TESTOSTERONE. Decision date: 12/17/2025 Comment Full text
FDA approves BORTEZOMIB from SHUANGCHENG FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Final approval of ANDA #ANDA #216528 for BORTEZOMIB. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for FLONASE SENSIMIST ALLERGY RELIEF FDA Approval Dec. 31, 2025, 13:45 UTC 34 0 comments Labeling changes approved for HALEON US HOLDINGS. Active ingredient: FLUTICASONE FUROATE. Decision date: 12/19/2025 Comment Full text
FDA approves NUFYMCO from FORMYCON AG FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Final approval of BLA #BLA #761473 for RANIBIZUMAB-LEYK. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for VARENICLINE TARTRATE FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Labeling changes approved for LUPIN LTD. Active ingredient: VARENICLINE TARTRATE. Decision date: 12/18/2025 Comment Full text
FDA approves DEFERIPRONE from SENORES PHARMS FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Final approval of ANDA #ANDA #220132 for DEFERIPRONE. Decision date: 12/11/2025 Comment Full text
FDA approves manufacturing change for NISOLDIPINE FDA Approval Dec. 31, 2025, 13:45 UTC 37 0 comments Manufacturing process update for AMTA. Submission: SUPPL-2. Decision date: 12/12/2025 Comment Full text
FDA updates labeling for NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 37 0 comments Labeling changes approved for SUN PHARM INDS LTD. Active ingredient: NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text