FDA updates labeling for PERCODAN FDA Approval Dec. 31, 2025, 13:45 UTC 24 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 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 CONZIP FDA Approval Dec. 31, 2025, 13:45 UTC 27 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 DILAUDID FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for FRESENIUS KABI USA. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 34 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NUCYNTA FDA Approval Dec. 31, 2025, 13:45 UTC 34 0 comments Labeling changes approved for COLLEGIUM PHARM INC. Active ingredient: TAPENTADOL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for SUBLIMAZE PRESERVATIVE FREE FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Labeling changes approved for RISING. Active ingredient: FENTANYL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA regulatory update for LUNSUMIO FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Administrative update #SUPPL-6 for GENENTECH INC. Status: Approval. Decision date: 12/19/2025 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 OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for ACTAVIS ELIZABETH. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text