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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
28/11/2024 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 20384 SODIUM RISEDRONATE HEMI-PENTAHYDRATE 2007-03-26 Active II Complete 2013-08-13 2012-12-11
28/11/2024 TAPI Technology & API Services
Israel
TEVA PHARMACEUTICAL INDUSTRIES LTD 16604 RISEDRONATE SODIUM 2003-05-22 Active II N/A