APPLICATION
NDA017717
TYPE
NDA
ORIGINAL APPROVAL
1976-03-24
LATEST ACTION
1999-11-03
ROUTE
VAGINAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GYNE-LOTRIMIN · ReferenceDiscontinued
CLOTRIMAZOLE 100MG · TABLET · VAGINAL
Approval history
1999-11-03Manufacturing (CMC) · Supplement 25AP
1998-03-17Manufacturing (CMC) · Supplement 23AP
1997-02-27Manufacturing (CMC) · Supplement 22AP
1992-10-08Labeling · Supplement 21 · standardAP
1992-06-23Manufacturing (CMC) · Supplement 19AP
1992-04-14Labeling · Supplement 20AP
1990-11-30Efficacy · Supplement 16AP
1987-06-18Manufacturing (CMC) · Supplement 14AP
1986-05-20Manufacturing (CMC) · Supplement 13AP
1982-09-16Labeling · Supplement 12AP
1981-11-12Labeling · Supplement 11AP
1981-08-05Manufacturing (CMC) · Supplement 8AP
1980-12-11Manufacturing (CMC) · Supplement 7AP
1980-09-23Labeling · Supplement 6AP
1979-07-23Manufacturing (CMC) · Supplement 4AP
1979-07-16Manufacturing (CMC) · Supplement 5AP
1978-05-18Manufacturing (CMC) · Supplement 3AP
1977-09-15Manufacturing (CMC) · Supplement 2AP
1977-08-09Manufacturing (CMC) · Supplement 1AP
1976-03-24UNKNOWN · Original · unknownAP
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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