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List of Drug Master Files (DMF) of Prestwick2_001119 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 Axplora
Germany
FARMABIOS SPA 22421 CLOCORTOLONE PIVALATE (MICRONIZED) 2009-01-21 Active II N/A
26/09/2024 ChemWerth Inc
U.S.A
CHEMWERTH INC 25138 CLOCORTOLONE PIVALATE 2011-09-09 Active II Complete 2014-10-07 2013-12-06