FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 113 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 98 0 comments Labeling changes approved for HOSPIRA INC. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYSINGLA ER FDA Approval Dec. 31, 2025, 13:45 UTC 113 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 106 0 comments Labeling changes approved for TEVA PHARMS USA. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BRIXADI FDA Approval Dec. 31, 2025, 13:45 UTC 91 0 comments Labeling changes approved for BRAEBURN. Active ingredient: BUPRENORPHINE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DSUVIA FDA Approval Dec. 31, 2025, 13:45 UTC 113 0 comments Labeling changes approved for VERTICAL PHARMS. Active ingredient: SUFENTANIL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for METHADONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 85 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 BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 108 0 comments Labeling changes approved for ETHYPHARM. Active ingredient: BUPRENORPHINE 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 92 0 comments Labeling changes approved for ABHAI LLC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 103 0 comments Labeling changes approved for PURACAP LABS BLU. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text