APPLICATION
ANDA074444
TYPE
ANDA
ORIGINAL APPROVAL
1997-01-13
LATEST ACTION
2025-08-29
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter
Products
MICONAZOLE NITRATEOver-the-counter
MICONAZOLE NITRATE 2% · CREAM · VAGINAL
Approval history
2025-08-29Manufacturing (CMC) · Supplement 23 · unknownAP
2006-10-05Labeling · Supplement 12AP
2005-04-08Labeling · Supplement 8AP
2002-11-27Manufacturing (CMC) · Supplement 7AP
1999-08-16Manufacturing (CMC) · Supplement 6AP
1998-01-28Manufacturing (CMC) · Supplement 5AP
1997-12-05Manufacturing (CMC) · Supplement 1AP
1997-12-05Manufacturing (CMC) · Supplement 4AP
1997-12-05Manufacturing (CMC) · Supplement 2AP
1997-08-06Manufacturing (CMC) · Supplement 3AP
1997-01-13OriginalAP
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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