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List of Drug Master Files (DMF) of 1-Pyrrolidineacetamide, alpha-ethyl-2-oxo-, (alphaS)- 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 Dr. Reddy\\\'s Laboratories
India
DR REDDYS LABORATORIES LTD 16966 LEVETIRACETAM 2003-11-17 Active II Complete 2013-01-30 2013-01-02
26/09/2024 IOL Chemicals and Pharmaceuticals
India
IOL CHEMICALS AND PHARMACEUTICALS LTD 36374 LEVETIRACETAM USP 2021-11-27 Active II N/A