FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 7 0 comments Labeling changes approved for ACTAVIS LABS FL INC. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYSINGLA ER FDA Approval Dec. 31, 2025, 13:45 UTC 17 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 TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 10 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 CODEINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for HIKMA. Active ingredient: CODEINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for AVANTHI INC. Active ingredient: OXYMORPHONE 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 13 0 comments Labeling changes approved for AMNEAL PHARMS. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 17 0 comments Labeling changes approved for RHODES PHARMS. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MORPHINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for HOSPIRA INC. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NALBUPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 12 0 comments Labeling changes approved for RISING. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text