FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 48 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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 52 0 comments Labeling changes approved for MIKART. 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 41 0 comments Labeling changes approved for CHARTWELL. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA expands indications for MOUNJARO FDA Approval Dec. 31, 2025, 13:45 UTC 51 0 comments ELI LILLY AND CO receives approval for new indications. Submission: SUPPL-39. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for PERCODAN FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for ENDO OPERATIONS. Active ingredient: ASPIRIN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DILAUDID FDA Approval Dec. 31, 2025, 13:45 UTC 49 0 comments Labeling changes approved for RHODES PHARMS. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYCODAN FDA Approval Dec. 31, 2025, 13:45 UTC 43 0 comments Labeling changes approved for GENUS. Active ingredient: HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE. 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 GENUS. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ACTIQ FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for CEPHALON. Active ingredient: FENTANYL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DEMEROL FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Labeling changes approved for HOSPIRA. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text