FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 63 0 comments Labeling changes approved for WES PHARMA INC. Active ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE 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 109 0 comments Labeling changes approved for HIKMA. Active ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for CODEINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 116 0 comments Labeling changes approved for HIKMA. Active ingredient: CODEINE SULFATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for OXYCODONE AND ACETAMINOPHEN FDA Approval Dec. 31, 2025, 13:45 UTC 73 0 comments Labeling changes approved for LANNETT CO INC. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for TUZISTRA XR FDA Approval Dec. 31, 2025, 13:45 UTC 45 0 comments Labeling changes approved for TRIS PHARMA INC. Active ingredient: CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ROXICET FDA Approval Dec. 31, 2025, 13:45 UTC 59 0 comments Labeling changes approved for HIKMA. Active ingredient: ACETAMINOPHEN; OXYCODONE 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 48 0 comments Labeling changes approved for CHARTWELL. 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 97 0 comments Labeling changes approved for SUN PHARM INDS LTD. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUTORPHANOL TARTRATE FDA Approval Dec. 31, 2025, 13:45 UTC 78 0 comments Labeling changes approved for HIKMA. Active ingredient: BUTORPHANOL TARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 45 0 comments Labeling changes approved for RHODES PHARMS. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text