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FDA Tentative Approval Letter – ANDA 216799 for Letermovir Tablets 240 mg & 480 mg (Zydus Pharms USA Inc.)
FDA Tentative Approval Letter – ANDA 216799 for Letermovir Tablets 240 mg & 480 mg (Zydus Pharms USA Inc.)
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Original Request Contents: Request a tentative approval letter for ANDA 216799 for Letermovir tablets 240 mg and 480 mg (Zydus Pharms USA Inc.).
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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