FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 31 0 comments Labeling changes approved for GENUS. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for SUBLIMAZE PRESERVATIVE FREE FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Labeling changes approved for RISING. Active ingredient: FENTANYL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MEPERIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 32 0 comments Labeling changes approved for STRIDES PHARMA INTL. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA regulatory update for ELELYSO FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Administrative update #SUPPL-34 for PFIZER. Status: Approval. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for METHADOSE FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Labeling changes approved for SPECGX LLC. Active ingredient: METHADONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ALFENTA FDA Approval Dec. 31, 2025, 13:45 UTC 34 0 comments Labeling changes approved for RISING. Active ingredient: ALFENTANIL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NUBAIN FDA Approval Dec. 31, 2025, 13:45 UTC 37 0 comments Labeling changes approved for PH HEALTH. Active ingredient: NALBUPHINE 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 30 0 comments Labeling changes approved for AMNEAL PHARMS NY. 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 35 0 comments Labeling changes approved for HOSPIRA. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA expands indications for MOUNJARO FDA Approval Dec. 31, 2025, 13:45 UTC 34 0 comments ELI LILLY AND CO receives approval for new indications. Submission: SUPPL-39. Decision date: 12/19/2025 Comment Full text