FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 55 0 comments Labeling changes approved for HOSPIRA INC. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NUCYNTA FDA Approval Dec. 31, 2025, 13:45 UTC 62 0 comments Labeling changes approved for COLLEGIUM PHARM INC. Active ingredient: TAPENTADOL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for CODEINE SULFATE FDA Approval Dec. 31, 2025, 13:45 UTC 68 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 49 0 comments Labeling changes approved for ASCENT PHARMS 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 40 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 37 0 comments Labeling changes approved for HIKMA. Active ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for BUTORPHANOL TARTRATE FDA Approval Dec. 31, 2025, 13:45 UTC 43 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 56 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 ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Approval Dec. 31, 2025, 13:45 UTC 40 0 comments Labeling changes approved for RHODES PHARMS. 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 43 0 comments Labeling changes approved for CHARTWELL. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text