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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 27661 RIVAROXABAN 2013-10-21 Active II Complete 2015-01-05 2014-11-21
24/02/2025 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 28121 RIVAROXABAN USP 2014-03-31 Active II Complete 2014-07-29 2014-05-12