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List of Drug Master Files (DMF) of Benztropine 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 Aspen API
Netherlands
FINE CHEMICALS CORP PTY LTD 6914 BENZTROPINE MESYLATE 1987-04-09 Active II Complete 2012-10-25 2012-12-19
26/09/2024 Dr. Reddy\\\'s Laboratories
India
DR REDDYS LABORATORIES LTD 7033 BENZTROPINE MESYLATE USP 1987-06-18 Active II Complete 2021-04-02 2021-03-30