FDA regulatory update for LUNSUMIO FDA Approval Dec. 31, 2025, 13:45 UTC 10 0 comments Administrative update #SUPPL-6 for GENENTECH INC. Status: Approval. Decision date: 12/19/2025 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 PROSTIN VR PEDIATRIC FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for PFIZER. Active ingredient: ALPROSTADIL. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for PERCOCET FDA Approval Dec. 31, 2025, 13:45 UTC 3 0 comments Labeling changes approved for ENDO OPERATIONS. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for CONZIP FDA Approval Dec. 31, 2025, 13:45 UTC 3 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 SUBOXONE FDA Approval Dec. 31, 2025, 13:45 UTC 4 0 comments Labeling changes approved for INDIVIOR. Active ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DILAUDID FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for RHODES PHARMS. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. 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 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 FENTORA FDA Approval Dec. 31, 2025, 13:45 UTC 2 0 comments Labeling changes approved for CEPHALON. Active ingredient: FENTANYL CITRATE. Decision date: 12/22/2025 Comment Full text