FDA updates labeling for CONZIP FDA Approval Dec. 31, 2025, 13:45 UTC 41 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 34 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 PERCOCET FDA Approval Dec. 31, 2025, 13:45 UTC 51 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 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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 59 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 54 0 comments Labeling changes approved for PHARM ASSOC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DILAUDID FDA Approval Dec. 31, 2025, 13:45 UTC 56 0 comments Labeling changes approved for RHODES PHARMS. Active ingredient: HYDROMORPHONE 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 50 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 29 0 comments Labeling changes approved for CEPHALON. Active ingredient: FENTANYL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MEPERIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 37 0 comments Labeling changes approved for GENUS. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text