Complete Response Letters
Novitium Pharma LLC: Hydroxychloroquine Sulfate
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Feb 12, 2021
Food, Drug, and Cosmetic Act for Hydroxychloroquine Sulfate Tablets.
CRL_NDA214581_20210212:p1:s12, of (2) conduct appropriate in vivo bioavailability or bioequivalence studies to bridge your proposed drug product to the listed drug.
CRL_NDA214581_20210212:p1:s23'ake before the application may be approved.
CRL_NDA214581_20210212:p2:s23More Complete Response Letters
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