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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 ZACH System SA
France
ZACH SYSTEM SA 11105 LOTEPREDNOL ETABONATE 1994-09-26 Active II Complete 2024-10-16 2024-10-08
28/03/2025 Axplora
Germany
FARMABIOS SPA 26937 LOTEPREDNOL ETABONATE 2013-03-05 Active II N/A