Complete Response Letters
Ingenus Pharmaceuticals, LLC: Cyclophosphamide
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jan 14, 2020
Drug, and Cosmetic Act for Cyclophosphamide Injection, 500 mg/2.5 mL and 1 g/5 mL.
CRL_NDA212501_20200114:p1:s12We also acknowledge receipt of your amendment dated December 26, 2019, which was not reviewed for this action.
CRL_NDA212501_20200114:p1:s14During a recent inspection of the | manufacturing facility for this application, our field investigator observed objectionable conditions at the facility and conveyed that information to the representative of the facility at the close of the inspection.
CRL_NDA212501_20200114:p1:s19Satisfactory resolution of the observations is required before this application may be approved.
CRL_NDA212501_20200114:p1:s20Do not submit actual inspectional correspondence to this application.
CRL_NDA212501_20200114:p1:s22More Complete Response Letters
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