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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