FDA updates labeling for DILAUDID FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Labeling changes approved for RHODES PHARMS. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for METHADONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for MYLAN INSTITUTIONAL. Active ingredient: METHADONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for SUFENTA PRESERVATIVE FREE FDA Approval Dec. 31, 2025, 13:45 UTC 19 0 comments Labeling changes approved for RISING. Active ingredient: SUFENTANIL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 9 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 ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for AMNEAL PHARMS NY. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MEPERIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Labeling changes approved for WATSON LABS. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA expands indications for MOUNJARO FDA Approval Dec. 31, 2025, 13:45 UTC 25 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 ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Labeling changes approved for PAI HOLDINGS. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 22 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 OXYCONTIN FDA Approval Dec. 31, 2025, 13:45 UTC 17 0 comments Labeling changes approved for PURDUE PHARMA LP. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text