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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 11405 ETODOLAC 1995-03-29 Active II Complete 2014-12-16 2014-11-28
28/03/2025 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 11766 ETODOLAC 1995-12-11 Active II Complete 2014-05-29 2012-11-08