FDA updates labeling for HYDROCODONE BITARTRATE AND IBUPROFEN FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Labeling changes approved for ACTAVIS LABS FL INC. Active ingredient: HYDROCODONE BITARTRATE; IBUPROFEN. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for METHADOSE FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for SPECGX LLC. Active ingredient: METHADONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NUBAIN FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for PH HEALTH. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for METHADONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Labeling changes approved for HIKMA. Active ingredient: METHADONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA approves DECITABINE from RELIANCE LIFE SCI FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Final approval of ANDA #ANDA #217814 for DECITABINE. Decision date: 12/19/2025 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 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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Labeling changes approved for PHARM ASSOC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. 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
FDA approves MYQORZO from CYTOKINETICS FDA Approval Dec. 31, 2025, 13:45 UTC 13 0 comments Final approval of NDA #NDA #219083 for AFICAMTEN. Decision date: 12/19/2025 Comment Full text