1 0

    FDA Approval Summary for AFINITOR DISPERZ (NDA 203985/S-13) – Summary Review, Medical Review, and Nonclinical Pharmacology/Toxicology review from April 10, 2018.

    FDA Approval Summary for AFINITOR DISPERZ (NDA 203985/S-13) – Summary Review, Medical Review, and Nonclinical Pharmacology/Toxicology review from April 10, 2018.

    $69.00 USD
    $69.00 USD
    Sale Sold out
    Original Request: Dear Sir/Madam: Please provide the Summary Review, Medical Review, and Nonclinical Pharmacology/Toxicology review from the summary basis of approval for the following: • AFINITOR DISPERZ (everolimus tablets for oral suspension); NDA 203985/Supplemental (S-13); FDA Approval on 10 April 2018 • etc
    • 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.

    View full details