FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for HIKMA. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for PAI HOLDINGS. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NALBUPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 36 0 comments Labeling changes approved for HOSPIRA. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ORILISSA FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for ABBVIE. Active ingredient: ELAGOLIX SODIUM. Decision date: 12/17/2025 Comment Full text
FDA regulatory update for Xeomin FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Administrative update #SUPPL-106 for MERZ PHARMS. Status: Approval. Decision date: 12/17/2025 Comment Full text
FDA regulatory update for LEQEMBI FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Administrative update #SUPPL-12 for EISAI INC. Status: Approval. Decision date: 12/15/2025 Comment Full text
FDA regulatory update for ABRILADA FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Administrative update #SUPPL-20 for PFIZER INC. Status: Approval. Decision date: 12/17/2025 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from TEVA PHARMS USA INC FDA Approval Dec. 31, 2025, 13:45 UTC 32 0 comments Tentative approval of ANDA #ANDA #211541 for DAPAGLIFLOZIN. Decision date: 12/18/2025 Comment Full text
FDA updates labeling for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Labeling changes approved for ALEMBIC PHARMS LTD. Active ingredient: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM. Decision date: 12/16/2025 Comment Full text
FDA approves BORTEZOMIB from SHUANGCHENG FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Final approval of ANDA #ANDA #216528 for BORTEZOMIB. Decision date: 12/17/2025 Comment Full text