APPLICATION
NDA020525
TYPE
NDA
ORIGINAL APPROVAL
1996-07-29
LATEST ACTION
2000-09-01
ROUTE
VAGINAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GYNE-LOTRIMIN 3 · ReferenceDiscontinued
CLOTRIMAZOLE 200MG · TABLET · VAGINAL
Approval history
2000-09-01Manufacturing (CMC) · Supplement 4 · standardAP
1999-12-13Manufacturing (CMC) · Supplement 3 · standardAP
1998-03-17Manufacturing (CMC) · Supplement 2 · standardAP
1997-02-27Manufacturing (CMC) · Supplement 1 · standardAP
1996-07-29Type 8 - Partial Rx to OTC Switch · 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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