FDA Patent Form 3542 for NDA 213674 – Xtandi (Enzalutamide) US Patent 12,161,628

FDA Patent Form 3542 for NDA 213674 – Xtandi (Enzalutamide) US Patent 12,161,628

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Original Request: I would like to request the Form "3542” for the US 12,161,628 for NDA #213674; Xtandi (Enzalutamide) oral tablet, (NDA holder – Astellas Pharma US INC).
Tags: Pharma, NDA, 2025
  • 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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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