FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 26 0 comments Labeling changes approved for GENUS. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NALBUPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 29 0 comments Labeling changes approved for HOSPIRA. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MEPERIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 25 0 comments Labeling changes approved for SUN PHARM INDS INC. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for DEMEROL FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Labeling changes approved for QUAGEN. 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 20 0 comments Labeling changes approved for SPECGX LLC. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Labeling changes approved for MIKART. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for MEPERIDINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Labeling changes approved for EPIC PHARMA LLC. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for FLOWTUSS FDA Approval Dec. 31, 2025, 13:45 UTC 20 0 comments Labeling changes approved for CHARTWELL RX. Active ingredient: GUAIFENESIN; HYDROCODONE BITARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ULTIVA FDA Approval Dec. 31, 2025, 13:45 UTC 24 0 comments Labeling changes approved for MYLAN INSTITUTIONAL. Active ingredient: REMIFENTANIL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for CODEINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 21 0 comments Labeling changes approved for HIKMA. Active ingredient: CODEINE SULFATE. Decision date: 12/22/2025 Comment Full text