APPLICATION
NDA017494
TYPE
NDA
ORIGINAL APPROVAL
1974-01-08
LATEST ACTION
2014-02-11
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
MONISTAT-DERMDiscontinued
MICONAZOLE NITRATE 2% · CREAM · TOPICAL
Approval history
2014-02-11Manufacturing (CMC) · Supplement 40 · standardAP
2014-02-11Manufacturing (CMC) · Supplement 65 · standardAP
2014-01-27Manufacturing (CMC) · Supplement 39 · standardAP
2014-01-02Manufacturing (CMC) · Supplement 37 · standardAP
2001-06-22Manufacturing (CMC) · Supplement 31 · standardAP
2001-03-20Manufacturing (CMC) · Supplement 32 · standardAP
1999-12-21Manufacturing (CMC) · Supplement 30 · standardAP
1998-11-12Manufacturing (CMC) · Supplement 29 · standardAP
1990-03-09Manufacturing (CMC) · Supplement 26 · standardAP
1988-10-17Labeling · Supplement 24AP
1986-09-17Manufacturing (CMC) · Supplement 23 · standardAP
1986-04-25Labeling · Supplement 22AP
1985-07-05Manufacturing (CMC) · Supplement 20 · standardAP
1985-06-24Manufacturing (CMC) · Supplement 21 · standardAP
1984-05-29Manufacturing (CMC) · Supplement 19 · standardAP
1983-06-02Manufacturing (CMC) · Supplement 18 · standardAP
1982-05-13Manufacturing (CMC) · Supplement 17 · standardAP
1982-04-19Manufacturing (CMC) · Supplement 16 · standardAP
1981-03-13Labeling · Supplement 14AP
1980-04-28Labeling · Supplement 13AP
1977-04-21Manufacturing (CMC) · Supplement 8 · standardAP
1976-12-16Labeling · Supplement 9AP
1975-12-30Manufacturing (CMC) · Supplement 5 · standardAP
1974-01-08Type 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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