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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Maithri Drugs |
India |
MAITHRI LABORATORIES PRIVATE LTD | 31959 | FLUCYTOSINE USP | 2017-08-30 | Active | II | Complete | 2022-08-24 | 2022-07-13 |
| 31/10/2025 | Actylis |
U.S.A |
ACETO CORP | 15476 | FLUCYTOSINE USP | 2001-06-07 | Inactive | II | N/A |
