FDA updates labeling for HYDROMORPHONE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 12 0 comments Labeling changes approved for HIKMA. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for FENTANYL CITRATE FDA Approval Dec. 31, 2025, 13:45 UTC 11 0 comments Labeling changes approved for EXELA PHARMA. Active ingredient: FENTANYL CITRATE. Decision date: 12/22/2025 Comment Full text
FDA approves POTASSIUM CHLORIDE from QUAGEN FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Final approval of ANDA #ANDA #215716 for POTASSIUM CHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for NALBUPHINE HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 5 0 comments Labeling changes approved for SOMERSET THERAPS LLC. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA approves WEGOVY from NOVO NORDISK INC FDA Approval Dec. 31, 2025, 13:45 UTC 12 0 comments Final approval of NDA #NDA #218316 for SEMAGLUTIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for LEVORPHANOL TARTRATE FDA Approval Dec. 31, 2025, 13:45 UTC 9 0 comments Labeling changes approved for SUN PHARM INDS INC. Active ingredient: LEVORPHANOL TARTRATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for QDOLO FDA Approval Dec. 31, 2025, 13:45 UTC 10 0 comments Labeling changes approved for ATHENA. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for LEVORPHANOL TARTRATE FDA Approval Dec. 31, 2025, 13:45 UTC 15 0 comments Labeling changes approved for NOVITIUM PHARMA. Active ingredient: LEVORPHANOL 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 18 0 comments Labeling changes approved for ELITE LABS INC. Active ingredient: ACETAMINOPHEN; CODEINE PHOSPHATE. Decision date: 12/22/2025 Comment Full text
FDA updates labeling for GAVRETO FDA Approval Dec. 31, 2025, 13:45 UTC 10 0 comments Labeling changes approved for RIGEL PHARMS. Active ingredient: PRALSETINIB. Decision date: 12/22/2025 Comment Full text