APPLICATION
NDA017619
TYPE
NDA
ORIGINAL APPROVAL
1975-03-18
LATEST ACTION
2007-12-07
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
LOTRIMIN · ReferenceDiscontinued
CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL
Approval history
2007-12-07Labeling · Supplement 29 · standardAP
2007-12-07Efficacy · Supplement 28 · unknownAP
2007-12-07Efficacy · Supplement 24AP
2002-01-10Manufacturing (CMC) · Supplement 35 · standardAP
2001-02-28Manufacturing (CMC) · Supplement 34 · standardAP
2001-01-29Manufacturing (CMC) · Supplement 33 · standardAP
1998-11-10Manufacturing (CMC) · Supplement 32 · standardAP
1998-05-29Manufacturing (CMC) · Supplement 31 · standardAP
1998-05-18Manufacturing (CMC) · Supplement 30 · standardAP
1992-06-23Manufacturing (CMC) · Supplement 26 · standardAP
1992-05-21Manufacturing (CMC) · Supplement 27 · standardAP
1990-02-06Manufacturing (CMC) · Supplement 25 · standardAP
1989-10-27Efficacy · Supplement 22AP
1987-10-29Manufacturing (CMC) · Supplement 21 · standardAP
1987-06-18Manufacturing (CMC) · Supplement 20 · standardAP
1986-09-12Manufacturing (CMC) · Supplement 19 · standardAP
1986-05-20Manufacturing (CMC) · Supplement 18 · standardAP
1986-04-23Manufacturing (CMC) · Supplement 17 · standardAP
1985-07-24Manufacturing (CMC) · Supplement 15 · standardAP
1985-05-20Labeling · Supplement 16AP
1984-07-03Labeling · Supplement 13AP
1984-07-03Labeling · Supplement 14AP
1981-10-13Manufacturing (CMC) · Supplement 11 · standardAP
1981-08-18Manufacturing (CMC) · Supplement 12 · standardAP
1981-06-04Manufacturing (CMC) · Supplement 10 · standardAP
1980-02-27Labeling · Supplement 9AP
1980-01-14Labeling · Supplement 8AP
1978-05-18Manufacturing (CMC) · Supplement 7 · standardAP
1978-01-16Manufacturing (CMC) · Supplement 6 · standardAP
1977-09-15Manufacturing (CMC) · Supplement 5 · standardAP
1977-08-09Manufacturing (CMC) · Supplement 4 · standardAP
1977-04-13Manufacturing (CMC) · Supplement 3 · standardAP
1976-09-16Manufacturing (CMC) · Supplement 2 · standardAP
1975-05-22Supplement · Supplement 1 · standardAP
1975-03-18Type 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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