Complete Response Letters
Roxane Laboratories, Inc.: Cyclophosphamide
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, May 3, 2013
Cyclophosphamide Capsules, 25 mg and 50 mg.
CRL_NDA203856_20130503:p1:s13At the time of your resubmission of this NDA, submit data from three registration batches (for each dosage strength) that conforms to the NDA-proposed specifications for dissolution and impurity levels.
CRL_NDA203856_20130503:p1:s238. Provide English translations of current approved foreign labeling not previously submitted.
CRL_NDA203856_20130503:p1:s48More Complete Response Letters
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