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List of Drug Master Files (DMF) of Clozapine Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 Cohance Lifesciences
India
COHANCE LIFESCIENCES LTD 31999 CLOZAPINE USP 2017-08-24 Active II Complete 2019-01-29 2018-12-07
26/09/2024 Medichem S.A
Spain
MEDICHEM SA 10534 CLOZAPINE 1993-10-21 Active II Complete 2015-01-29 2015-01-26