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FDA Approval – Varenicline Tablets ANDA 216723
FDA Approval – Varenicline Tablets ANDA 216723
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Original Request: Dear Sir/ Madam, Can you please provide summary basis of approval for quality section of following ANDA? Product Name: Varenicline Tablets Strength: 0.5 & 1mg ANDA No: 216723
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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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