FDA Application Review Records for LEQSELVI Tablets (NDA 217900)

FDA Application Review Records for LEQSELVI Tablets (NDA 217900)

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Original Request: Unredacted copies of "Product Quality Review", "Multi-Discipline Review", "Proprietary Name Review", "Other Review(s)", and "Administrative and Correspondence Documents" posted around August 23, 2024 to accessdata.fda.gov as part of the FDA Application Review Files for Sun's approved drug LEQSELVI, 8MG Tablets (Application number 217900) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217900Orig1s000TOC.cfm)
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. 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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