FDA approves ACETAMINOPHEN AND IBUPROFEN from TARO FDA Approval Jan. 06, 2026, 15:52 UTC 9 0 comments Final approval of ANDA #ANDA #219053 for ACETAMINOPHEN; IBUPROFEN. Decision date: 01/02/2026 Comment Full text
FDA approves EXTENDED PHENYTOIN SODIUM from MANKIND PHARMA FDA Approval Jan. 06, 2026, 09:50 UTC 5 0 comments Final approval of ANDA #ANDA #219773 for PHENYTOIN SODIUM. Decision date: 01/02/2026 Comment Full text
FDA updates labeling for CARBAMAZEPINE FDA Approval Jan. 06, 2026, 09:50 UTC 4 0 comments Labeling changes approved for AMNEAL PHARMS. Active ingredient: CARBAMAZEPINE. Decision date: 01/05/2026 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from ALKEM LABS LTD FDA Approval Jan. 05, 2026, 09:58 UTC 12 0 comments Tentative approval of ANDA #ANDA #211545 for DAPAGLIFLOZIN. Decision date: 01/02/2026 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from JIANGSU HANSOH PHARM FDA Approval Dec. 31, 2025, 13:45 UTC 3 0 comments Tentative approval of ANDA #ANDA #216119 for DAPAGLIFLOZIN. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for ORLADEYO FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Labeling changes approved for BIOCRYST. Active ingredient: BEROTRALSTAT DIHYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA expands indications for PYRUKYND FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments AGIOS PHARMS INC receives approval for new indications. Submission: SUPPL-3. Decision date: 12/23/2025 Comment Full text
FDA grants tentative approval for NINTEDANIB from GLENMARK PHARMS LTD FDA Approval Dec. 31, 2025, 13:45 UTC 7 0 comments Tentative approval of ANDA #ANDA #212555 for NINTEDANIB ESYLATE. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for YONDELIS FDA Approval Dec. 31, 2025, 13:45 UTC 7 0 comments Labeling changes approved for JANSSEN PRODS. Active ingredient: TRABECTEDIN. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for ORLYNVAH FDA Approval Dec. 31, 2025, 13:45 UTC 1 0 comments Labeling changes approved for ITERUM THERAP. Active ingredient: PROBENECID; SULOPENEM ETZADROXIL. Decision date: 12/23/2025 Comment Full text