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
TADLIQ — FDA Complete Response Letter (NDA 214522)
Issued to CMP Development LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 23, 2021Application
NDA 505b1 • 214522
Product
TADLIQ
Company
CMP Development LLC
Review center
Other
Stage
Final Decision
Response due
January 1, 2024
Assyro regulatory brief
FreeWhat did FDA decide for TADLIQ?
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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 TADLIQ complete response letter
What does this complete response letter mean for TADLIQ?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to CMP Development LLC on February 23, 2021.
What is NDA 214522?
NDA 214522 is the application under which FDA issued this complete response letter for TADLIQ to CMP Development LLC. It was reviewed by FDA Other. The letter is dated February 23, 2021.
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.