FDA updates labeling for NUCYNTA FDA Approval Dec. 31, 2025, 13:45 UTC 22 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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 19 0 comments Labeling changes approved for EPIC PHARMA LLC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 32 0 comments Labeling changes approved for HIKMA. Active ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OBREDON FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Labeling changes approved for SOVEREIGN PHARMS. Active ingredient: GUAIFENESIN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for PHARMOBEDIENT. Active ingredient: ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Labeling changes approved for HOSPIRA INC. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Labeling changes approved for TEVA PHARMS USA. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for CODEINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Labeling changes approved for HIKMA. Active ingredient: CODEINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for ACTAVIS LABS FL INC. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 36 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text