FDA updates labeling for DILAUDID FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Labeling changes approved for RHODES PHARMS. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for FIORICET W/ CODEINE FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Labeling changes approved for ACTAVIS LABS UT INC. Active ingredient: ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA approves BONCRESA from AMNEAL PHARMS LLC FDA Approval Dec. 31, 2025, 13:45 UTC 17 0 comments Final approval of BLA #BLA #761456 for DENOSUMAB. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for VIVITROL FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for ALKERMES. Active ingredient: NALTREXONE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for CODEINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for HIKMA. Active ingredient: CODEINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NUCYNTA FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for COLLEGIUM PHARM INC. Active ingredient: TAPENTADOL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DEMEROL FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for QUAGEN. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Labeling changes approved for INGENUS PHARMS NJ. Active ingredient: ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Labeling changes approved for HIKMA. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text