APPLICATION
NDA018181
TYPE
NDA
ORIGINAL APPROVAL
1979-01-15
LATEST ACTION
2001-08-29
ROUTE
Topical, TOPICAL
DOSAGE FORM
Solution, SOLUTION
MARKETING STATUS
Over-the-counter, Discontinued
Products
MYCELEXOver-the-counter
CLOTRIMAZOLE 1% · Solution · Topical
MYCELEX · ReferenceDiscontinued
CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · TOPICAL
Approval history
2001-08-29Manufacturing (CMC) · Supplement 11 · standardAP
2001-08-29Manufacturing (CMC) · Supplement 10 · standardAP
1997-05-13Manufacturing (CMC) · Supplement 9 · standardAP
1995-04-03Labeling · Supplement 8AP
1993-05-12Manufacturing (CMC) · Supplement 7 · standardAP
1991-04-01Labeling · Supplement 6AP
1990-03-16Labeling · Supplement 5AP
1979-01-15Type 5 - New Formulation or New Manufacturer · 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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