Complete Response Letters
Laurus Generics, Inc.: NDA 217719
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Mar 10, 2025
We acknowledge receipt of your major amendment dated), which extended the goal date by three months.
CRL_NDA217719_20250310:p1:s15The product may not be distributed until you have been notified in writing that this application is tentatively approved.
CRL_NDA217719_20250310:p1:s47More Complete Response Letters
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