FDA approves BECLOMETHASONE DIPROPIONATE from AMNEAL IRELAND LTD FDA Approval Dec. 31, 2025, 13:45 UTC 3 0 comments Final approval of ANDA #ANDA #213811 for BECLOMETHASONE DIPROPIONATE. Decision date: 12/16/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for MACLEODS PHARMS LTD. Active ingredient: ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE FDA Approval Dec. 31, 2025, 13:45 UTC 4 0 comments Labeling changes approved for ALEMBIC PHARMS LTD. Active ingredient: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
FDA approves HALOPERIDOL from CREEKWOOD PHARMS FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Final approval of ANDA #ANDA #218162 for HALOPERIDOL. Decision date: 12/18/2025 Comment Full text
FDA approves NUFYMCO from FORMYCON AG FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Final approval of BLA #BLA #761473 for RANIBIZUMAB-LEYK. Decision date: 12/18/2025 Comment Full text
FDA approves CARIPRAZINE HYDROCHLORIDE from AUROBINDO PHARMA LTD FDA Approval Dec. 31, 2025, 13:45 UTC 0 0 comments Final approval of ANDA #ANDA #213982 for CARIPRAZINE HYDROCHLORIDE. Decision date: 12/16/2025 Comment Full text
FDA approves manufacturing change for FLUTICASONE PROPIONATE FDA Approval Dec. 31, 2025, 13:45 UTC 1 0 comments Manufacturing process update for AUROBINDO PHARMA LTD. Submission: SUPPL-1. Decision date: 12/16/2025 Comment Full text
FDA updates labeling for XTANDI FDA Approval Dec. 31, 2025, 13:45 UTC 1 0 comments Labeling changes approved for ASTELLAS. Active ingredient: ENZALUTAMIDE. Decision date: 12/11/2025 Comment Full text
FDA updates labeling for NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for SUN PHARM INDS LTD. Active ingredient: NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 0 0 comments Labeling changes approved for TEVA. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/11/2025 Comment Full text