Complete Response Letters
SQ Innovation, Inc.: furosemide
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jan 12, 2024
(12) We acknowledge your draft labeling submitted on Ls cigicgeraieciort We reserve further comment on the proposed labeling until the application is otherwise adequate.
CRL_NDA217294_20240112:p1:s46Submit draft carton and container labeling based on our proposed revisions date:
CRL_NDA217294_20240112:p1:s51If your user interface is revised in response to the Complete Response, additional human factors considerations may apply.
CRL_NDA217294_20240112:p2:s13More Complete Response Letters
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