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    FDA NDA Approval Package – THIOLA (Tiopronin) Tablet 100 mg (NDA 019569, Azurity Pharmaceuticals, Inc.)

    FDA NDA Approval Package – THIOLA (Tiopronin) Tablet 100 mg (NDA 019569, Azurity Pharmaceuticals, Inc.)

    $69.00 USD
    $69.00 USD
    Sale Sold out
    Original Request Contents: Azurity Pharmaceuticals, Inc. requests the drug product approval package for NDA 019569 for THIOLA (tiopronin) Tablet 100 mg; include Original NDA Approval Letter, Product Quality Review(s), Clinical Pharmacology/Biopharmaceutics Review(s), Clinical Review(s), Non-Clinical Review(s), Proprietary Name Review(s), Other Review(s), Statistical Review(s), Summary Review, and Administrative/Correspondence Documents
    • 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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