APPLICATION
ANDA074760
TYPE
ANDA
ORIGINAL APPROVAL
1997-05-15
LATEST ACTION
2017-08-21
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter
Products
MICONAZOLE NITRATEOver-the-counter
MICONAZOLE NITRATE 2% · CREAM · VAGINAL
Approval history
2017-08-21Labeling · Supplement 37 · standardAP
2005-04-14Labeling · Supplement 15AP
2004-08-17Labeling · Supplement 9AP
2002-01-30Labeling · Supplement 4AP
2002-01-30Labeling · Supplement 5AP
1999-06-08Manufacturing (CMC) · Supplement 3AP
1998-09-25Manufacturing (CMC) · Supplement 2AP
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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