APPLICATION
NDA018052
TYPE
NDA
ORIGINAL APPROVAL
1978-11-08
LATEST ACTION
2010-04-12
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
GYNE-LOTRIMIN · ReferenceDiscontinued
CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · VAGINAL
Approval history
2002-01-16Manufacturing (CMC) · Supplement 30 · standardAP
2001-02-02Manufacturing (CMC) · Supplement 29 · standardAP
2000-09-01Manufacturing (CMC) · Supplement 28 · standardAP
2000-01-20Manufacturing (CMC) · Supplement 27 · standardAP
1998-12-09Manufacturing (CMC) · Supplement 26 · standardAP
1998-08-11Manufacturing (CMC) · Supplement 25 · standardAP
1993-09-22Manufacturing (CMC) · Supplement 18 · standardAP
1993-04-26Efficacy · Supplement 24 · unknownAP
1993-04-21Manufacturing (CMC) · Supplement 21 · standardAP
1993-04-15Manufacturing (CMC) · Supplement 23 · standardAP
1992-10-08Labeling · Supplement 22 · standardAP
1992-06-23Manufacturing (CMC) · Supplement 17 · standardAP
1992-05-12Labeling · Supplement 20AP
1992-04-14Labeling · Supplement 19AP
1990-11-30Efficacy · Supplement 12AP
1990-09-11Manufacturing (CMC) · Supplement 14 · standardAP
1988-10-04Manufacturing (CMC) · Supplement 13 · standardAP
1987-06-18Manufacturing (CMC) · Supplement 11 · standardAP
1986-12-04Labeling · Supplement 4AP
1986-09-12Manufacturing (CMC) · Supplement 10 · standardAP
1986-05-20Manufacturing (CMC) · Supplement 9 · standardAP
1985-07-24Manufacturing (CMC) · Supplement 7 · standardAP
1981-10-09Manufacturing (CMC) · Supplement 5 · standardAP
1981-08-17Manufacturing (CMC) · Supplement 6 · standardAP
1981-03-27Manufacturing (CMC) · Supplement 3 · standardAP
1980-01-03Manufacturing (CMC) · Supplement 2 · standardAP
1979-11-27Labeling · Supplement 1AP
1978-11-08Type 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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