FDA updates labeling for NUCYNTA FDA Approval Dec. 31, 2025, 13:45 UTC 39 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 DSUVIA FDA Approval Dec. 31, 2025, 13:45 UTC 46 0 comments Labeling changes approved for VERTICAL PHARMS. Active ingredient: SUFENTANIL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ROXYBOND FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for PROTEGA PHARMS. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for SUBLOCADE FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for INDIVIOR. Active ingredient: BUPRENORPHINE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Labeling changes approved for ASCENT PHARMS INC. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE FDA Approval Dec. 31, 2025, 13:45 UTC 39 0 comments Labeling changes approved for INTL MEDICATION. 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 36 0 comments Labeling changes approved for FOSUN PHARMA. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Labeling changes approved for FOSUN PHARMA. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for ACTAVIS ELIZABETH. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for CHARTWELL RX. Active ingredient: CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text