Complete Response Letters
Bayer HealthCare LLC: Naproxen sodium
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jun 13, 2024
FDA conducted an expedited, risk-based review of the available information from the inspection and determined that the deficiencies represent significant issues that adversely impact the facility's ability to perform the designated functions described in your application.
CRL_NDA218506_20240613:p1:s35Complete Response Letter, the facility will be informed.
CRL_NDA218506_20240613:p1:s43Otherwise, further assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.
CRL_NDA218506_20240613:p1:s44(8) Provide English translations of current approved foreign labeling not previously submitted.
CRL_NDA218506_20240613:p2:s10More Complete Response Letters
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.