APPLICATION
ANDA076357
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-30
LATEST ACTION
2017-08-21
ROUTE
TOPICAL, VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter
Products
MICONAZOLE 3 COMBINATION PACKOver-the-counter
MICONAZOLE NITRATE 2%,4% · CREAM · TOPICAL, VAGINAL
Approval history
2017-08-21Labeling · Supplement 30 · standardAP
2005-04-12Labeling · Supplement 5AP
2004-03-30OriginalAP
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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