Complete Response Letters
Actavis, L.L.C.: Pemetrexed Injection
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Sep 26, 2017
Cosmetic Act for Pemetrexed Injection) 25 mg/mL.
CRL_NDA208419_20170926:p1:s12During recent inspection of Sindan-Pharma S.R.L (FEI: 3005566806) manufacturing facility for this application, our field investigators conveyed deficiencies to the representative of the facility.
CRL_NDA208419_20170926:p1:s16Satisfactory resolution of these deficiencies is required before this application may be approved.
CRL_NDA208419_20170926:p1:s17More Complete Response Letters
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