Approval Documents – Lumryz (NDA #214755, Approval Letter, Labeling, REMS, Review Files, Sponsor Communications)

Approval Documents – Lumryz (NDA #214755, Approval Letter, Labeling, REMS, Review Files, Sponsor Communications)

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Request Contents: Approval and regulatory documents for Lumryz (NDA #214755), including the approval letter, labeling, review files, REMS-related documents, and sponsor communications.
  • 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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