FDA updates labeling for SYNALGOS-DC FDA Approval Dec. 31, 2025, 13:45 UTC 41 0 comments Labeling changes approved for SUN PHARM INDUSTRIES. Active ingredient: ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE. 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 OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 51 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DILAUDID FDA Approval Dec. 31, 2025, 13:45 UTC 39 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 NUCYNTA FDA Approval Dec. 31, 2025, 13:45 UTC 57 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 37 0 comments Labeling changes approved for RISING. Active ingredient: FENTANYL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA regulatory update for ELELYSO FDA Approval Dec. 31, 2025, 13:45 UTC 37 0 comments Administrative update #SUPPL-34 for PFIZER. Status: Approval. Decision date: 12/22/2025 Comment Full text
FDA regulatory update for LUNSUMIO FDA Approval Dec. 31, 2025, 13:45 UTC 54 0 comments Administrative update #SUPPL-6 for GENENTECH INC. Status: Approval. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for METHADONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 53 0 comments Labeling changes approved for MYLAN INSTITUTIONAL. Active ingredient: METHADONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
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