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List of Drug Master Files (DMF) of Fampridine 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 Seqens
France
CU CHEMIE UETIKON GMBH 17860 DALFAMPRIDINE 2004-11-29 Active II N/A
26/09/2024 Alkem Laboratories
India
ALKEM LABORATORIES LTD 27637 DALFAMPRIDINE USP 2013-11-01 Active II Complete 2014-01-24 2013-11-19