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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 04/06/2025 | Derivados Quimicos SAU |
Spain |
DERIVADOS QUIMICOS SAU | 18981 | BUTOCONAZOLE NITRATE | 2005-11-29 | Active | II | N/A | ||
| 04/06/2025 | F. Hoffmann-La Roche |
Switzerland |
KV PHARMACEUTICAL CO | 9585 | BUTOCONAZOLE NITRATE 2% VAGINAL CREAM | 1992-03-19 | Inactive | II | N/A |
