FDA updates labeling for METHADONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 36 0 comments Labeling changes approved for ELITE LABS INC. Active ingredient: METHADONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 61 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ZUBSOLV FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Labeling changes approved for OREXO US INC. Active ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DSUVIA FDA Approval Dec. 31, 2025, 13:45 UTC 61 0 comments Labeling changes approved for VERTICAL PHARMS. Active ingredient: SUFENTANIL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BRIXADI FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Labeling changes approved for BRAEBURN. Active ingredient: BUPRENORPHINE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for XTAMPZA ER FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Labeling changes approved for COLLEGIUM PHARM INC. Active ingredient: OXYCODONE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYSINGLA ER FDA Approval Dec. 31, 2025, 13:45 UTC 61 0 comments Labeling changes approved for PURDUE PHARMA LP. Active ingredient: HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 56 0 comments Labeling changes approved for HOSPIRA INC. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 23 0 comments Labeling changes approved for ACTAVIS ELIZABETH. Active ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 55 0 comments Labeling changes approved for INTL MEDICATION SYS. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text