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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
28/03/2025 Apicore
India
APICORE US LLC 20438 FELBAMATE 2007-04-12 Inactive II N/A
28/03/2025 Emcure Pharmaceuticals
India
EMCURE PHARMACEUTICALS LTD 29408 FELBAMATE USP 2015-06-26 Active II Complete 2015-10-02 2015-07-08