Issued to Sun Pharmaceutical Industries Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 25, 2024Application
NDA 505b1 • 215644
Product
Unknown
Company
Sun Pharmaceutical Industries Limited
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Sun Pharmaceutical Industries Limited on October 25, 2024.
NDA 215644 is the application under which FDA issued this complete response letter for Unknown to Sun Pharmaceutical Industries Limited. It was reviewed by FDA CDER. The letter is dated October 25, 2024.
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.