FDA updates labeling for ULTIVA FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for MYLAN INSTITUTIONAL. Active ingredient: REMIFENTANIL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for REZDIFFRA FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for MADRIGAL. Active ingredient: RESMETIROM. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for MEPERIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for STRIDES PHARMA INTL. Active ingredient: MEPERIDINE 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 6 0 comments Labeling changes approved for GENUS. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for METHADOSE FDA Approval Dec. 31, 2025, 13:45 UTC 9 0 comments Labeling changes approved for SPECGX LLC. Active ingredient: METHADONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NUBAIN FDA Approval Dec. 31, 2025, 13:45 UTC 10 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 4 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 ALFENTA FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for RISING. Active ingredient: ALFENTANIL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NALBUPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Labeling changes approved for HOSPIRA. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA regulatory update for ELELYSO FDA Approval Dec. 31, 2025, 13:45 UTC 2 0 comments Administrative update #SUPPL-34 for PFIZER. Status: Approval. Decision date: 12/22/2025 Comment Full text