FDA updates labeling for FENTANYL-100 FDA Approval Dec. 31, 2025, 13:45 UTC 4 0 comments Labeling changes approved for SPECGX LLC. Active ingredient: FENTANYL. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for TRAMADOL HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 7 0 comments Labeling changes approved for AMNEAL PHARMS. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for METHADONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 9 0 comments Labeling changes approved for HIKMA. 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 8 0 comments Labeling changes approved for HOSPIRA. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 11 0 comments Labeling changes approved for STRIDES PHARMA INTL. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 14 0 comments Labeling changes approved for STRIDES PHARMA INTL. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 4 0 comments Labeling changes approved for LGM PHARMA. Active ingredient: ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUTORPHANOL TARTRATE FDA Approval Dec. 31, 2025, 13:45 UTC 1 0 comments Labeling changes approved for HIKMA. Active ingredient: BUTORPHANOL TARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MEPERIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for BARR. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Labeling changes approved for PHARMOBEDIENT. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text