APPLICATION
NDA018520
TYPE
NDA
ORIGINAL APPROVAL
1982-03-15
LATEST ACTION
2013-07-10
ROUTE
VAGINAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Over-the-counter
Products
MONISTAT 7 · ReferenceOver-the-counter
MICONAZOLE NITRATE 100MG · SUPPOSITORY · VAGINAL
Approval history
2013-07-10Manufacturing (CMC) · Supplement 24 · standardAP
1999-03-26Manufacturing (CMC) · Supplement 16 · standardAP
1998-03-17Manufacturing (CMC) · Supplement 15 · standardAP
1992-10-08Labeling · Supplement 14 · standardAP
1992-06-03Labeling · Supplement 12AP
1991-02-15Efficacy · Supplement 11AP
1986-09-11Manufacturing (CMC) · Supplement 10 · standardAP
1985-09-04Manufacturing (CMC) · Supplement 9 · standardAP
1985-06-24Manufacturing (CMC) · Supplement 7 · standardAP
1985-06-24Manufacturing (CMC) · Supplement 6 · standardAP
1983-07-27Labeling · Supplement 5AP
1983-06-02Manufacturing (CMC) · Supplement 4 · standardAP
1982-09-20Labeling · Supplement 3AP
1982-05-13Manufacturing (CMC) · Supplement 2 · standardAP
1982-04-19Manufacturing (CMC) · Supplement 1 · standardAP
1982-03-15Type 3 - New Dosage Form · Original · standardAP
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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