FDA Approval – Varenicline Tablets (Zydus)

FDA Approval – Varenicline Tablets (Zydus)

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Original Request: Please provide Summary Basis of Approval for BE Section of VARENICLINE TARTRATE TABLET ORAL EQ 0.5MG BASE and EQ 1MG BASE for the Applicant ZYDUS WORLDWIDE DMCC - A216723
  • 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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