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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 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 26266 CARBAMAZEPINE 2012-07-31 Active II Complete 2015-12-16 2015-06-25
28/03/2025 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 4719 CARBAMAZEPINE USP 1982-11-10 Active II Complete 2012-11-30 2012-11-13