Issued to Mylan Laboratories Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 1, 2017Application
NDA 505b1 • 206610
Product
ACETAMINOPHEN
Company
Mylan Laboratories Limited
Review center
Other
Stage
Final Decision
Response due
January 1, 2022
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence. 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 Mylan Laboratories Limited on February 1, 2017.
NDA 206610 is the application under which FDA issued this complete response letter for ACETAMINOPHEN to Mylan Laboratories Limited. It was reviewed by FDA Other. The letter is dated February 1, 2017.
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.