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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 | IOL Chemicals and Pharmaceuticals |
India |
IOL CHEMICALS AND PHARMACEUTICALS LTD | 36535 | FENOFIBRATE USP | 2022-01-05 | Active | II | Complete | 2024-02-05 | 2023-12-22 |
28/03/2025 | Moehs Iberica |
Spain |
MOEHS IBERICA SL | 19119 | MICRONIZED FENOFIBRATE & FENOFIBRATE | 2006-01-16 | Active | II | Complete | 2017-08-17 | 2017-07-31 |