APPLICATION
NDA020288
TYPE
NDA
ORIGINAL APPROVAL
1993-04-26
LATEST ACTION
2013-07-10
ROUTE
TOPICAL, VAGINAL
DOSAGE FORM
CREAM, SUPPOSITORY
MARKETING STATUS
Over-the-counter
Products
MONISTAT 7 COMBINATION PACK · ReferenceOver-the-counter
MICONAZOLE NITRATE 2%,100MG · CREAM, SUPPOSITORY · TOPICAL, VAGINAL
Approval history
2013-07-10Manufacturing (CMC) · Supplement 17 · standardAP
2002-10-28Manufacturing (CMC) · Supplement 9 · standardAP
2002-04-10Manufacturing (CMC) · Supplement 8 · standardAP
2000-01-20Manufacturing (CMC) · Supplement 7 · standardAP
1999-10-04Manufacturing (CMC) · Supplement 5 · standardAP
1999-03-26Manufacturing (CMC) · Supplement 4 · standardAP
1998-03-17Manufacturing (CMC) · Supplement 3 · standardAP
1997-03-21Manufacturing (CMC) · Supplement 2 · standardAP
1996-08-15Manufacturing (CMC) · Supplement 1 · standardAP
1993-04-26Type 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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