Complete Response Letters
Ricon Pharma, LLC: Cyclophosphamide
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jul 18, 2019
Drug, and Cosmetic Act for Cyclophosphamide Injection, 500 mg/2.5 mL and 1 g/5 mL.
CRL_NDA212501_20190718:p1:s12During a recent inspection of the | manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.
CRL_NDA212501_20190718:p1:s16Satisfactory resolution of these deficiencies is required before this application may be approved.
CRL_NDA212501_20190718:p1:s17'ake before the application may be approved.
CRL_NDA212501_20190718:p2:s3More Complete Response Letters
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