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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 FARMAK, a.s
Czech Republic
FARMAK AS 15486 ZOLPIDEM TARTRATE 2001-06-21 Active II Complete 2019-04-11 2019-04-05
28/03/2025 Sanofi
France
SANOFI WINTHROP INDUSTRIE 20984 ZOLPIDEM TARTRATE 2007-10-30 Active II N/A