APPLICATION
NDA017613
TYPE
NDA
ORIGINAL APPROVAL
1975-02-03
LATEST ACTION
2007-12-07
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LOTRIMIN · ReferenceDiscontinued
CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · TOPICAL
Approval history
2007-12-07Labeling · Supplement 22 · standardAP
2007-12-07Efficacy · Supplement 21 · unknownAP
2007-12-07Efficacy · Supplement 18AP
2001-03-08Manufacturing (CMC) · Supplement 26 · priorityAP
2001-02-28Manufacturing (CMC) · Supplement 27 · priorityAP
2000-09-07Manufacturing (CMC) · Supplement 25 · priorityAP
1998-05-28Manufacturing (CMC) · Supplement 24 · priorityAP
1998-05-18Manufacturing (CMC) · Supplement 23 · priorityAP
1992-06-23Manufacturing (CMC) · Supplement 20 · priorityAP
1991-10-25Manufacturing (CMC) · Supplement 19 · priorityAP
1989-10-27Efficacy · Supplement 15AP
1989-04-06Manufacturing (CMC) · Supplement 17 · priorityAP
1987-06-18Manufacturing (CMC) · Supplement 14 · priorityAP
1986-05-20Manufacturing (CMC) · Supplement 13 · priorityAP
1985-05-20Labeling · Supplement 12AP
1984-08-06Manufacturing (CMC) · Supplement 10 · priorityAP
1984-07-03Labeling · Supplement 9AP
1984-07-03Labeling · Supplement 11AP
1981-08-05Manufacturing (CMC) · Supplement 8 · priorityAP
1980-04-09Manufacturing (CMC) · Supplement 7 · priorityAP
1978-05-18Manufacturing (CMC) · Supplement 6 · priorityAP
1977-09-13Manufacturing (CMC) · Supplement 5 · priorityAP
1977-08-09Manufacturing (CMC) · Supplement 4 · priorityAP
1977-04-13Labeling · Supplement 3AP
1976-06-29Labeling · Supplement 2AP
1975-04-22Labeling · Supplement 1AP
1975-02-03Type 1 - New Molecular Entity · Original · priorityAP
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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