Issued to nnoPharma Licensing LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 27, 2015Application
NDA 505b1 • 206968
Product
ACETAMINOPHEN
Company
nnoPharma Licensing LLC
Review center
Other
Stage
Final Decision
Response due
June 30, 2023
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Nonclinical evidence, Chemistry, manufacturing, and controls. 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 nnoPharma Licensing LLC on February 27, 2015.
NDA 206968 is the application under which FDA issued this complete response letter for ACETAMINOPHEN to nnoPharma Licensing LLC. It was reviewed by FDA Other. The letter is dated February 27, 2015.
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.