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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 | Actylis |
U.S.A |
ACETO CORP | 15476 | FLUCYTOSINE USP | 2001-06-07 | Inactive | II | N/A | ||
28/03/2025 | Calyx Chemicals & Pharmaceuticals Limited |
India |
CALYX CHEMICALS AND PHARMACEUTICALS LTD | 23503 | FLUCYTOSINE | 2010-01-22 | Active | II | N/A |