FDA updates labeling for FENTANYL-100 FDA Approval Dec. 31, 2025, 13:45 UTC 42 0 comments Labeling changes approved for KINDEVA. Active ingredient: FENTANYL. 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
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 49 0 comments Labeling changes approved for EPIC PHARMA LLC. 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 56 0 comments Labeling changes approved for SUN PHARM. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. 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 OBREDON FDA Approval Dec. 31, 2025, 13:45 UTC 47 0 comments Labeling changes approved for SOVEREIGN PHARMS. Active ingredient: GUAIFENESIN; HYDROCODONE BITARTRATE. 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 TEVA PHARMS USA. Active ingredient: MORPHINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 56 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 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 54 0 comments Labeling changes approved for RHODES PHARMS. Active ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text