FDA regulatory update for LUNSUMIO FDA Approval Dec. 31, 2025, 13:45 UTC 9 0 comments Administrative update #SUPPL-6 for GENENTECH INC. Status: Approval. Decision date: 12/19/2025 Comment Full text
FDA approves JASCAYD from BOEHRINGER INGELHEIM FDA Approval Dec. 31, 2025, 13:45 UTC 4 0 comments Final approval of NDA #NDA #220449 for NERANDOMILAST. Decision date: 12/19/2025 Comment Full text
FDA updates labeling for METHADOSE FDA Approval Dec. 31, 2025, 13:45 UTC 10 0 comments Labeling changes approved for SPECGX LLC. Active ingredient: METHADONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for FENTANYL CITRATE FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for HIKMA. Active ingredient: FENTANYL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for PHENERGAN VC W/ CODEINE FDA Approval Dec. 31, 2025, 13:45 UTC 2 0 comments Labeling changes approved for ANI PHARMS. Active ingredient: CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for VIVITROL FDA Approval Dec. 31, 2025, 13:45 UTC 10 0 comments Labeling changes approved for ALKERMES. Active ingredient: NALTREXONE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; 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 8 0 comments Labeling changes approved for ACTAVIS ELIZABETH. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ULTIVA FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Labeling changes approved for MYLAN INSTITUTIONAL. Active ingredient: REMIFENTANIL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ROXICODONE FDA Approval Dec. 31, 2025, 13:45 UTC 3 0 comments Labeling changes approved for SPECGX LLC. Active ingredient: OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text