APPLICATION
ANDA074136
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-04
LATEST ACTION
2001-08-30
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
MICONAZOLE NITRATEDiscontinued
MICONAZOLE NITRATE 2% · CREAM · VAGINAL
Approval history
2001-08-30Manufacturing (CMC) · Supplement 9AP
2000-07-07Manufacturing (CMC) · Supplement 8AP
1996-08-01Manufacturing (CMC) · Supplement 7AP
1996-06-13Manufacturing (CMC) · Supplement 5AP
1996-05-14Manufacturing (CMC) · Supplement 6AP
1996-05-14Labeling · Supplement 1AP
1996-01-23Manufacturing (CMC) · Supplement 4AP
1996-01-23Manufacturing (CMC) · Supplement 3AP
1995-01-04OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.