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 TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 36 0 comments Labeling changes approved for PURACAP LABS BLU. Active ingredient: TRAMADOL HYDROCHLORIDE. 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 ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE FDA Approval Dec. 31, 2025, 13:45 UTC 32 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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 36 0 comments Labeling changes approved for GENUS. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NALBUPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for RISING. Active ingredient: NALBUPHINE HYDROCHLORIDE. 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 37 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 METHADONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Labeling changes approved for SPECGX LLC. Active ingredient: METHADONE HYDROCHLORIDE. 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 ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 39 0 comments Labeling changes approved for AUROLIFE PHARMA LLC. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text