Source facts
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
US FDA source recordCRL · Complete Response Letter
Unknown — FDA Complete Response Letter (NDA 210168)
Issued to Cipla USA, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 20, 2025Application
NDA 505b1 • 210168
Product
Unknown
Company
Cipla USA, Inc.
Review center
CDERStage
Final Decision
Response due
June 20, 2026
Assyro regulatory brief
FreeWhat did FDA decide for Unknown?
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Key details in this letter
- 1Labeling, packaging, and proprietary name: 10 source-text matches.
Labeling, packaging, and proprietary name
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the Unknown complete response letter
What does this complete response letter mean for Unknown?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Cipla USA, Inc. on June 20, 2025.
What is NDA 210168?
NDA 210168 is the application under which FDA issued this complete response letter for Unknown to Cipla USA, Inc.. It was reviewed by FDA CDER. The letter is dated June 20, 2025.
What happens after an FDA complete response letter?
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.