FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for TEVA PHARMS USA. Active ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE 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 8 0 comments Labeling changes approved for AUROLIFE PHARMA LLC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DSUVIA FDA Approval Dec. 31, 2025, 13:45 UTC 14 0 comments Labeling changes approved for VERTICAL PHARMS. Active ingredient: SUFENTANIL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYCODONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for VISTAPHARM LLC. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA expands indications for FUROSCIX FDA Approval Dec. 31, 2025, 13:45 UTC 2 0 comments SCPHARMACEUTICALS receives approval for new indications. Submission: SUPPL-4. 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 3 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 FENTANYL-100 FDA Approval Dec. 31, 2025, 13:45 UTC 15 0 comments Labeling changes approved for ZYDUS PHARMS. Active ingredient: FENTANYL. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 9 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NUCYNTA ER FDA Approval Dec. 31, 2025, 13:45 UTC 8 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 MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Labeling changes approved for IMPAX LABS INC. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text