Complete Response Letters
Grace Therapeutics U.S., Inc.: nimodipine
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Apr 23, 2026
The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA Form 483 prior to your complete response.
CRL_NDA220304_20260423:p1:s25More Complete Response Letters
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