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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.
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