APPLICATION
NDA018888
TYPE
NDA
ORIGINAL APPROVAL
1984-08-15
LATEST ACTION
2014-02-27
ROUTE
VAGINAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription
Products
MONISTAT 3 · ReferencePrescription
MICONAZOLE NITRATE 200MG · SUPPOSITORY · VAGINAL
Approval history
2014-02-27Manufacturing (CMC) · Supplement 18 · standardAP
2014-02-11Manufacturing (CMC) · Supplement 17 · standardAP
2013-07-10Manufacturing (CMC) · Supplement 15 · standardAP
2013-02-07Manufacturing (CMC) · Supplement 14 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 10 · standardAP
1999-09-22Manufacturing (CMC) · Supplement 9 · standardAP
1998-10-07Manufacturing (CMC) · Supplement 7 · standardAP
1988-10-17Labeling · Supplement 6AP
1986-09-17Manufacturing (CMC) · Supplement 5 · standardAP
1986-04-25Labeling · Supplement 4AP
1985-07-05Manufacturing (CMC) · Supplement 1 · standardAP
1985-06-25Manufacturing (CMC) · Supplement 2 · standardAP
1984-08-15Type 5 - New Formulation or New Manufacturer · 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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