APPLICATION
ANDA074586
TYPE
ANDA
ORIGINAL APPROVAL
1997-07-17
LATEST ACTION
2002-11-21
ROUTE
TOPICAL, VAGINAL
DOSAGE FORM
CREAM, SUPPOSITORY
MARKETING STATUS
Discontinued
Products
M-ZOLE 7 DUAL PACKDiscontinued
MICONAZOLE NITRATE 2%,100MG · CREAM, SUPPOSITORY · TOPICAL, VAGINAL
Approval history
2002-11-21Labeling · Supplement 6AP
2002-01-08Manufacturing (CMC) · Supplement 5AP
2000-12-29Manufacturing (CMC) · Supplement 4AP
2000-02-09Labeling · Supplement 3AP
1999-04-30Manufacturing (CMC) · Supplement 2AP
1998-10-01Labeling · Supplement 1AP
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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