FDA updates labeling for PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for HIKMA. Active ingredient: CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for CONZIP FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for CIPHER PHARMS INC. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for PERCODAN FDA Approval Dec. 31, 2025, 13:45 UTC 23 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 OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 32 0 comments Labeling changes approved for ACTAVIS ELIZABETH. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for FIORICET W/ CODEINE FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Labeling changes approved for ACTAVIS LABS UT INC. Active ingredient: ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for PHENERGAN VC W/ CODEINE FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Labeling changes approved for ANI PHARMS. Active ingredient: CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA regulatory update for ELELYSO FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Administrative update #SUPPL-34 for PFIZER. Status: Approval. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ALFENTA FDA Approval Dec. 31, 2025, 13:45 UTC 35 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 38 0 comments Labeling changes approved for PH HEALTH. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for METHADONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for MYLAN INSTITUTIONAL. Active ingredient: METHADONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text