APPLICATION
NDA018813
TYPE
NDA
ORIGINAL APPROVAL
1984-02-17
LATEST ACTION
2007-12-07
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued
Products
LOTRIMINDiscontinued
CLOTRIMAZOLE 1% · LOTION · TOPICAL
Approval history
2007-12-07Efficacy · Supplement 17 · unknownAP
2007-12-07Labeling · Supplement 18 · standardAP
2007-12-07Labeling · Supplement 12AP
2007-12-07Efficacy · Supplement 10AP
2002-01-10Manufacturing (CMC) · Supplement 23 · standardAP
2001-03-06Manufacturing (CMC) · Supplement 22 · standardAP
2000-09-07Manufacturing (CMC) · Supplement 21 · standardAP
1999-05-14Manufacturing (CMC) · Supplement 20 · standardAP
1998-05-18Manufacturing (CMC) · Supplement 19 · standardAP
1993-07-02Manufacturing (CMC) · Supplement 16 · standardAP
1993-02-12Manufacturing (CMC) · Supplement 15 · standardAP
1992-06-23Manufacturing (CMC) · Supplement 14 · standardAP
1991-10-25Manufacturing (CMC) · Supplement 13 · standardAP
1991-03-07Manufacturing (CMC) · Supplement 11 · standardAP
1989-10-27Efficacy · Supplement 7AP
1989-04-06Manufacturing (CMC) · Supplement 9 · standardAP
1987-06-18Manufacturing (CMC) · Supplement 6 · standardAP
1986-05-20Manufacturing (CMC) · Supplement 5 · standardAP
1985-05-20Labeling · Supplement 4AP
1985-04-16Manufacturing (CMC) · Supplement 3 · standardAP
1984-08-06Labeling · Supplement 2AP
1984-08-06Manufacturing (CMC) · Supplement 1 · standardAP
1984-02-17Type 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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