Complete Response Letters
Nanocopoeia, LLC: NDA 217379
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jun 14, 2024
We also acknowledge receipt of your amendment dated oe , which was not reviewed for this action.
CRL_NDA217379_20240614:p1:s14, listed in this application, FDA conveyed deficiencies to the representative of the facility.
CRL_NDA217379_20240614:p1:s47The facility should provide satisfactory responses to these deficiencies indicated on the FDA 483 to the FDA office prior to your complete response to your application.
CRL_NDA217379_20240614:p1:s48More Complete Response Letters
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