FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 5 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 MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 4 0 comments Labeling changes approved for HIKMA. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUTRANS FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for PURDUE PHARMA LP. Active ingredient: BUPRENORPHINE. Decision date: 12/22/2025 Comment Full text
FDA regulatory update for Xeomin FDA Approval Dec. 31, 2025, 13:45 UTC 10 0 comments Administrative update #SUPPL-106 for MERZ PHARMS. Status: Approval. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for PRINSTON INC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for ORILISSA FDA Approval Dec. 31, 2025, 13:45 UTC 4 0 comments Labeling changes approved for ABBVIE. Active ingredient: ELAGOLIX SODIUM. Decision date: 12/17/2025 Comment Full text
FDA regulatory update for ABRILADA FDA Approval Dec. 31, 2025, 13:45 UTC 4 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 0 0 comments Tentative approval of ANDA #ANDA #211541 for DAPAGLIFLOZIN. Decision date: 12/18/2025 Comment Full text
FDA approves BORTEZOMIB from SHUANGCHENG FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Final approval of ANDA #ANDA #216528 for BORTEZOMIB. Decision date: 12/17/2025 Comment Full text
FDA regulatory update for LEQEMBI FDA Approval Dec. 31, 2025, 13:45 UTC 7 0 comments Administrative update #SUPPL-12 for EISAI INC. Status: Approval. Decision date: 12/15/2025 Comment Full text