Complete Response Letters

OWP Pharmaceuticals, Inc.: NDA 218879

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 3, 2025

, Proposed to support the application is not operational.

Complete Response Letter · Jan 3, 2025Open the letter ↗CRL_NDA218879_20250103:p1:s67

Note that the application cannot be approved if any proposed facility for the commercial manufacturing is not acceptable for the proposed function on the action date.

Complete Response Letter · Jan 3, 2025Open the letter ↗CRL_NDA218879_20250103:p1:s72

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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.