FDA expands indications for VRAYLAR FDA Approval Dec. 31, 2025, 13:45 UTC 54 0 comments ABBVIE receives approval for new indications. Submission: SUPPL-14. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE FDA Approval Dec. 31, 2025, 13:45 UTC 53 0 comments Labeling changes approved for ALEMBIC PHARMS LTD. Active ingredient: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
FDA updates labeling for CIPROFLOXACIN HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Labeling changes approved for UNIQUE. Active ingredient: CIPROFLOXACIN HYDROCHLORIDE. Decision date: 12/17/2025 Comment Full text
FDA approves HALOPERIDOL from CREEKWOOD PHARMS FDA Approval Dec. 31, 2025, 13:45 UTC 51 0 comments Final approval of ANDA #ANDA #218162 for HALOPERIDOL. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for TIZANIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 51 0 comments Labeling changes approved for APOTEX INC. Active ingredient: TIZANIDINE HYDROCHLORIDE. Decision date: 12/16/2025 Comment Full text
FDA approves manufacturing change for FLUTICASONE PROPIONATE FDA Approval Dec. 31, 2025, 13:45 UTC 49 0 comments Manufacturing process update for AUROBINDO PHARMA LTD. Submission: SUPPL-1. Decision date: 12/16/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 52 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 XTANDI FDA Approval Dec. 31, 2025, 13:45 UTC 46 0 comments Labeling changes approved for ASTELLAS. Active ingredient: ENZALUTAMIDE. Decision date: 12/11/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 45 0 comments Labeling changes approved for TEVA. Active ingredient: TRAMADOL HYDROCHLORIDE. 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 51 0 comments Labeling changes approved for SUN PHARM INDS LTD. Active ingredient: NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE. Decision date: 12/15/2025 Comment Full text