FDA updates labeling for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for ALEMBIC PHARMS LTD. Active ingredient: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
FDA regulatory update for GAZYVA FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Administrative update #SUPPL-40 for GENENTECH. Status: Approval. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for GABAPENTIN FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Labeling changes approved for SANDOZ. Active ingredient: GABAPENTIN. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for LOSARTAN POTASSIUM FDA Approval Dec. 31, 2025, 13:45 UTC 13 0 comments Labeling changes approved for HETERO LABS LTD V. Active ingredient: LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
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 updates labeling for TIZANIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 28 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 22 0 comments Manufacturing process update for AUROBINDO PHARMA LTD. Submission: SUPPL-1. Decision date: 12/16/2025 Comment Full text
FDA regulatory update for LEQEMBI FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Administrative update #SUPPL-12 for EISAI INC. Status: Approval. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for VINCRISTINE SULFATE PFS FDA Approval Dec. 31, 2025, 13:45 UTC 19 0 comments Labeling changes approved for HOSPIRA. Active ingredient: VINCRISTINE SULFATE. Decision date: 12/17/2025 Comment Full text
FDA expands indications for RUBRACA FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments PHARMAAND receives approval for new indications. Submission: SUPPL-14. Decision date: 12/17/2025 Comment Full text