APPLICATION
ANDA074164
TYPE
ANDA
ORIGINAL APPROVAL
1996-03-29
LATEST ACTION
2022-04-27
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter
Products
MICONAZOLE 7Over-the-counter
MICONAZOLE NITRATE 2% · CREAM · VAGINAL
Approval history
2022-04-27Labeling · Supplement 33 · standardAP
2015-06-08Manufacturing (CMC) · Supplement 27 · unknownAP
2015-03-24Labeling · Supplement 22AP
2015-03-24Labeling · Supplement 25 · standardAP
2001-11-19Labeling · Supplement 10AP
2000-12-29Manufacturing (CMC) · Supplement 8AP
2000-02-17Manufacturing (CMC) · Supplement 6AP
1999-12-27Manufacturing (CMC) · Supplement 7AP
1996-10-18Manufacturing (CMC) · Supplement 3AP
1996-10-18Manufacturing (CMC) · Supplement 1AP
1996-10-18Manufacturing (CMC) · Supplement 4AP
1996-10-18Manufacturing (CMC) · Supplement 2AP
1996-06-28Manufacturing (CMC) · Supplement 5AP
1996-03-29OriginalAP
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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