FDA NDA 216483 Review Package for Pivya (pivmecillinam hydrochloride)

FDA NDA 216483 Review Package for Pivya (pivmecillinam hydrochloride)

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Original Request: FDA approved the drug Pivya (pivmecillinam hydrochloride) -- NDA 216483 -- on 4/24/24. Though it has been over 30 days since the drug's approval, the review is still not available on the Drugs@FDA database.
Tags: Pharma, 483, 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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