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FDA Review Documents – Diastat AcuDial (NDA: 020648)
FDA Review Documents – Diastat AcuDial (NDA: 020648)
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Original Request: Dear Sir or Madam, Aucta phramaceuticals, Inc. is requesting the review documents for the Diastat AcuDial (NDA: 020648) 20MG/4ML and 10MG/2ML: 1. summary review; 2. clinical pharmacology biopharmaceutics review; 3. pharmacology review; 4. administrative documents & correspondence. Please see the approval letter in the attachment.
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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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