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FDA ANDA · ANDA091366
BASIC CARE MICONAZOLE 3
miconazole nitrate
Sponsor: PERRIGO R AND D
APPLICATION
ANDA091366
TYPE
ANDA
ORIGINAL APPROVAL
2010-01-15
LATEST ACTION
2017-08-21
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter
Products
MICONAZOLE NITRATEOver-the-counter
MICONAZOLE NITRATE 4% · CREAM · VAGINAL
Approval history
2017-08-21Labeling · Supplement 1 · standardAP
2010-01-15OriginalAP
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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