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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
24/02/2025 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 20581 TOPIRAMATE 2007-06-06 Active II Complete 2015-04-03 2013-05-21
24/02/2025 Alembic Pharmaceuticals Limited
India
ALEMBIC PHARMACEUTICALS LTD 27439 TOPIRAMATE 2013-09-30 Inactive II N/A