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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 | Sanofi |
France |
SANOFI WINTHROP INC | 5355 | DIATRIZOATE SODIUM USP | 1984-04-11 | Inactive | II | N/A | ||
24/02/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 28739 | DIATRIZOATE SODIUM | 2014-11-05 | Active | II | Complete | 2015-06-09 | 2015-04-08 |