APPLICATION
NDA018183
TYPE
NDA
ORIGINAL APPROVAL
1979-01-15
LATEST ACTION
2001-08-29
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
MYCELEXDiscontinued
CLOTRIMAZOLE 1% · CREAM · TOPICAL
Approval history
2001-08-29Manufacturing (CMC) · Supplement 19 · standardAP
2001-08-29Manufacturing (CMC) · Supplement 21 · standardAP
2000-09-21Manufacturing (CMC) · Supplement 20 · standardAP
1999-08-06Manufacturing (CMC) · Supplement 18 · standardAP
1999-08-06Manufacturing (CMC) · Supplement 16 · standardAP
1999-08-06Manufacturing (CMC) · Supplement 17 · standardAP
1996-08-15Manufacturing (CMC) · Supplement 15 · standardAP
1996-06-03Labeling · Supplement 14AP
1995-04-03Labeling · Supplement 13AP
1993-05-12Manufacturing (CMC) · Supplement 12 · standardAP
1993-01-29Manufacturing (CMC) · Supplement 11 · standardAP
1992-08-07Manufacturing (CMC) · Supplement 10 · standardAP
1991-04-01Labeling · Supplement 8AP
1991-03-29Labeling · Supplement 9AP
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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