Approval Letters – ANDAs: 213926 (Emtricitabine/Renofovir alafenamide, 12/13/2024); 216608 (Aripiprazole, 12/03/2024); 218787 (Darolutamide, 11/22/2024); 218544 (Nilotinib, 10/02/2024)

Approval Letters – ANDAs: 213926 (Emtricitabine/Renofovir alafenamide, 12/13/2024); 216608 (Aripiprazole, 12/03/2024); 218787 (Darolutamide, 11/22/2024); 218544 (Nilotinib, 10/02/2024)

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Request Contents: Approval letters for ANDAs: 12/13/2024: ANDA No. 213926 for Emtricitabine; Renofovir alafenamide fumarate. 12/03/2024: ANDA No. 216608 for Aripiprazole. 11/22/2024: ANDA No. 218787 for Darolutamide. 10/02/2024: ANDA No. 218544 for Nilotinib. Not available on Drugs@FDA website.
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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