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List of Drug Master Files (DMF) of Loteprednol Etabonate 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 ZACH System SA
France
ZACH SYSTEM SA 11105 LOTEPREDNOL ETABONATE 1994-09-26 Active II N/A
26/09/2024 Axplora
Germany
FARMABIOS SPA 26937 LOTEPREDNOL ETABONATE 2013-03-05 Active II N/A