FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 10 0 comments Labeling changes approved for INTL MEDICATION SYS. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for CODEINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 9 0 comments Labeling changes approved for HIKMA. Active ingredient: CODEINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 15 0 comments Labeling changes approved for HOSPIRA INC. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for METHADONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 7 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 TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 12 0 comments Labeling changes approved for PURACAP LABS BLU. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BRIXADI FDA Approval Dec. 31, 2025, 13:45 UTC 4 0 comments Labeling changes approved for BRAEBURN. Active ingredient: BUPRENORPHINE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Labeling changes approved for OSMOTICA PHARM US. 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 19 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 OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 9 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DSUVIA FDA Approval Dec. 31, 2025, 13:45 UTC 15 0 comments Labeling changes approved for VERTICAL PHARMS. Active ingredient: SUFENTANIL CITRATE. Decision date: 12/22/2025 Comment Full text