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List of Drug Master Files (DMF) of Prestwick3_000541 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 Interquim SA
Spain
INTERQUIM SA 18929 CICLOPIROX USP 2005-11-02 Active II N/A
26/09/2024 Seqens
France
PCAS 17007 CICLOPIROX 2003-12-01 Active II Complete 2013-10-05 2013-09-30