FDA updates labeling for NALBUPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Labeling changes approved for RISING. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ZUBSOLV FDA Approval Dec. 31, 2025, 13:45 UTC 23 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 HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Labeling changes approved for PADAGIS US. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DSUVIA FDA Approval Dec. 31, 2025, 13:45 UTC 44 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 28 0 comments Labeling changes approved for BRAEBURN. Active ingredient: BUPRENORPHINE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYSINGLA ER FDA Approval Dec. 31, 2025, 13:45 UTC 47 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 XTRELUS FDA Approval Dec. 31, 2025, 13:45 UTC 42 0 comments Labeling changes approved for ECI PHARMS LLC. Active ingredient: GUAIFENESIN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for XTAMPZA ER FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for COLLEGIUM PHARM INC. Active ingredient: OXYCODONE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 43 0 comments Labeling changes approved for HOSPIRA INC. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 37 0 comments Labeling changes approved for INTL MEDICATION SYS. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text