FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 4 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 FENTANYL CITRATE FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for HOSPIRA. Active ingredient: FENTANYL 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 7 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ACTIQ FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Labeling changes approved for CEPHALON. Active ingredient: FENTANYL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for PERCODAN FDA Approval Dec. 31, 2025, 13:45 UTC 7 0 comments Labeling changes approved for ENDO OPERATIONS. Active ingredient: ASPIRIN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA expands indications for MOUNJARO FDA Approval Dec. 31, 2025, 13:45 UTC 9 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 HYCODAN FDA Approval Dec. 31, 2025, 13:45 UTC 5 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 5 0 comments Labeling changes approved for GENUS. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DEMEROL FDA Approval Dec. 31, 2025, 13:45 UTC 2 0 comments Labeling changes approved for HOSPIRA. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NUCYNTA FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for COLLEGIUM PHARM INC. Active ingredient: TAPENTADOL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text