APPLICATION
NDA020289
TYPE
NDA
ORIGINAL APPROVAL
1993-04-26
LATEST ACTION
2000-02-22
ROUTE
TOPICAL, VAGINAL
DOSAGE FORM
CREAM, TABLET
MARKETING STATUS
Discontinued
Products
GYNE-LOTRIMIN COMBINATION PACK · ReferenceDiscontinued
CLOTRIMAZOLE 1%,100MG · CREAM, TABLET · TOPICAL, VAGINAL
Approval history
2000-02-22Manufacturing (CMC) · Supplement 4 · standardAP
1998-12-09Manufacturing (CMC) · Supplement 3 · standardAP
1998-03-17Manufacturing (CMC) · Supplement 2 · standardAP
1997-03-06Manufacturing (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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