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FDA HYDROXYUREA NDA 075734 Approval/Review Summary Documents
FDA HYDROXYUREA NDA 075734 Approval/Review Summary Documents
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Original Request: We are looking for HYDROXYUREA (application# 075734) approval/review summary i.e. Recent Printed Labeling, Summary Review, Medical Review(s), Chemistry Review(s), Pharmacology Review(s), and Clinical Pharmacology Biopharmaceutics Review(s).
Tags: Pharma, ANDA, 2024
Tags: Pharma, ANDA, 2024
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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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