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FDA Review Files – NDA 214755 Lumryz Starter Pack Approval
FDA Review Files – NDA 214755 Lumryz Starter Pack Approval
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Original Request: Please provide copies of the review files for the supplemental NDA application for Lumryz (NDA #214755) related to the September 26, 2024 approval for inclusion of a starter pack. Please provide the documents electronically if possible.
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- 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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