APPLICATION
NDA019084
TYPE
NDA
ORIGINAL APPROVAL
1985-12-31
LATEST ACTION
2007-12-07
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
NIZORAL · ReferenceDiscontinued
KETOCONAZOLE 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL
Approval history
2007-12-07Labeling · Supplement 22 · standardAP
2002-04-02Manufacturing (CMC) · Supplement 31 · standardAP
2002-03-08Manufacturing (CMC) · Supplement 30 · standardAP
1999-12-30Manufacturing (CMC) · Supplement 28 · standardAP
1998-12-04Manufacturing (CMC) · Supplement 27 · standardAP
1998-05-26Manufacturing (CMC) · Supplement 26 · standardAP
1998-05-26Manufacturing (CMC) · Supplement 24 · standardAP
1998-02-09Manufacturing (CMC) · Supplement 23 · standardAP
1996-10-08Manufacturing (CMC) · Supplement 21 · standardAP
1996-07-09Manufacturing (CMC) · Supplement 20 · standardAP
1996-04-16Labeling · Supplement 19 · standardAP
1995-11-17Manufacturing (CMC) · Supplement 18 · standardAP
1995-11-17Manufacturing (CMC) · Supplement 17 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 16 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 14 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 15 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 13 · standardAP
1993-10-07Manufacturing (CMC) · Supplement 12 · standardAP
1993-01-28Manufacturing (CMC) · Supplement 10 · standardAP
1993-01-28Manufacturing (CMC) · Supplement 11 · standardAP
1993-01-27Efficacy · Supplement 9AP
1990-10-12Manufacturing (CMC) · Supplement 8 · standardAP
1990-01-31Manufacturing (CMC) · Supplement 7 · standardAP
1988-11-14Labeling · Supplement 6AP
1988-11-01Manufacturing (CMC) · Supplement 4 · standardAP
1988-10-17Labeling · Supplement 1AP
1987-11-03Manufacturing (CMC) · Supplement 5 · standardAP
1987-07-28Manufacturing (CMC) · Supplement 3 · standardAP
1987-07-28Manufacturing (CMC) · Supplement 2 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.