Issued to Almatica Pharma, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 13, 2023Application
NDA 505b1 • 215721
Product
ZOLPIDEM TARTRATE
Company
Almatica Pharma, LLC
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
Assyro regulatory brief
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Almatica Pharma, LLC on January 13, 2023.
NDA 215721 is the application under which FDA issued this complete response letter for ZOLPIDEM TARTRATE to Almatica Pharma, LLC. It was reviewed by FDA Other. The letter is dated January 13, 2023.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.