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    FDA Summary Review Files for NDA 019430 (Epipen) and NDA 214697 (Neffy)

    FDA Summary Review Files for NDA 019430 (Epipen) and NDA 214697 (Neffy)

    $69.00 USD
    $69.00 USD
    Sale Sold out
    Original Request: The Summary Review files (previously known as the Summary Basis of Approval) for the below two NDAs: -NDA 019430, Epipen 0.3mg/delivery and Epipen Jr. 0.15mg/delivery IM/SC Injectable, held under Mylan Specialty LP -NDA 214697, Neffy (epinephrine) Nasal Spray, 2mg/spray, held under ARS Pharmaceuticals Operations Inc.
    Tags: Pharma, NDA, 2024
    • 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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