Issued to Adamis Pharmaceuticals Corporation. Application reviewed but not approved; deficiencies must be corrected.
Issued
November 13, 2020Application
NDA 505b1 • 212854
Product
ZIMHI
Company
Adamis Pharmaceuticals Corporation
Review center
Other
Stage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Safety and adverse events, Statistical analysis. 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.
Open the document workspaceFDA source document
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Adamis Pharmaceuticals Corporation on November 13, 2020.
NDA 212854 is the application under which FDA issued this complete response letter for ZIMHI to Adamis Pharmaceuticals Corporation. It was reviewed by FDA Other. The letter is dated November 13, 2020.
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.