FDA Approved: GYNAZOLE 1 — Original Application (Padagis Israel Pharmaceuticals Ltd)

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Summary

FDA approved GYNAZOLE 1 as an original application for a generic butoconazole nitrate vaginal antifungal, manufactured by Padagis Israel Pharmaceuticals Ltd.

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Diseases / indications

• Vulvovaginal Candidiasis

Drugs mentioned

• GYNAZOLE 1 (BUTOCONAZOLE NITRATE)

Snippet

ORIG AP for GYNAZOLE 1 (BUTOCONAZOLE NITRATE)