APPLICATION
ANDA074030
TYPE
ANDA
ORIGINAL APPROVAL
1992-10-30
LATEST ACTION
1999-03-23
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
MICONAZOLE NITRATEDiscontinued
MICONAZOLE NITRATE 2% · CREAM · VAGINAL
Approval history
1999-03-23Manufacturing (CMC) · Supplement 12AP
1998-06-11Manufacturing (CMC) · Supplement 11AP
1996-12-04Manufacturing (CMC) · Supplement 10AP
1996-05-31Manufacturing (CMC) · Supplement 8AP
1994-06-20Labeling · Supplement 7AP
1994-04-11Labeling · Supplement 6AP
1993-11-19Manufacturing (CMC) · Supplement 1AP
1993-11-05Manufacturing (CMC) · Supplement 5AP
1993-11-05Labeling · Supplement 3AP
1993-07-21Labeling · Supplement 4AP
1993-02-03Labeling · Supplement 2AP
1992-10-30OriginalAP
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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