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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 |