APPLICATION
ANDA200923
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-18
LATEST ACTION
2015-06-17
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
GYNAZOLE-1Prescription
BUTOCONAZOLE NITRATE 2% · CREAM · VAGINAL
Approval history
2015-06-17Labeling · Supplement 4 · standardAP
2012-05-18Not Applicable · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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