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Complete Response Letters

Emory Partners, LLC: Dyanavel XR

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, Jan 21, 2021

Food, Drug, and Cosmetic Act for Dyanavel XR (amphetamine) extended-release tablets 5 mg, 10 mg, 15 mg, and 20 mg.
Complete Response Letter · Jan 21, 2021 · p. 2Open the letter at p. 2 ↗CRL_NDA210526_20210121:p1:s12
Satisfactory resolution of these deficiencies is required before this application may be approved.
Complete Response Letter · Jan 21, 2021 · p. 2Open the letter at p. 2 ↗CRL_NDA210526_20210121:p1:s19

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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.