Complete Response Letters

Scienture Inc.: losartan potassium

What FDA's Complete Response Letters to the company say, in the letters' own words.

EphemerisX Research · Sep 30, 2026 · Sources: FDA, SEC

Complete Response Letter, Aug 19, 2024

(4) Given the outstanding product quality deficiencies, the acceptability of the drug product lot used in the relative bioavailability study (Study 14323/21-22) and food effect study (Study 14324/21-22) will be assessed after you have resubmitted your NDA.

Complete Response Letter · Aug 19, 2024 · p. 3Open the letter at p. 3 ↗CRL_NDA218772_20240819:p1:s18

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Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.