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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 | Sanofi |
France |
SANOFI WINTHROP INDUSTRIE | 14809 | CLOPIDOGREL BISULFATE FORM II | 2000-03-31 | Active | II | N/A | ||
28/03/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 34334 | CLOPIDOGREL BISULFATE USP | 2020-02-05 | Active | II | N/A |