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FDA ANDA · ANDA079114
UP AND UP MICONAZOLE
miconazole nitrate
Sponsor: PERRIGO R AND D
APPLICATION
ANDA079114
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-02
LATEST ACTION
2020-06-11
ROUTE
TOPICAL, VAGINAL
DOSAGE FORM
CREAM, INSERT, CREAM
MARKETING STATUS
Over-the-counter
Products
MICONAZOLE NITRATEOver-the-counter
MICONAZOLE NITRATE 2%,1.2GM · CREAM, INSERT · TOPICAL, VAGINAL
MICONAZOLE NITRATEOver-the-counter
MICONAZOLE NITRATE 2% · CREAM · TOPICAL, VAGINAL
Approval history
2020-06-11Labeling · Supplement 14 · standardAP
2017-08-25Labeling · Supplement 6 · standardAP
2010-06-02OriginalAP
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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