FDA updates labeling for BELBUCA FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Labeling changes approved for BDSI. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for XTRELUS FDA Approval Dec. 31, 2025, 13:45 UTC 43 0 comments Labeling changes approved for ECI PHARMS LLC. Active ingredient: GUAIFENESIN; 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 37 0 comments Labeling changes approved for ABHAI LLC. 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 33 0 comments Labeling changes approved for ABHAI 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 45 0 comments Labeling changes approved for VERTICAL PHARMS. Active ingredient: SUFENTANIL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for FENTANYL-100 FDA Approval Dec. 31, 2025, 13:45 UTC 43 0 comments Labeling changes approved for ZYDUS PHARMS. Active ingredient: FENTANYL. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 44 0 comments Labeling changes approved for UPSHER SMITH LABS. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 42 0 comments Labeling changes approved for ETHYPHARM. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 51 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Labeling changes approved for AVANTHI INC. Active ingredient: OXYMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text