APPLICATION
NDA019927
TYPE
NDA
ORIGINAL APPROVAL
1990-08-31
LATEST ACTION
2014-01-08
ROUTE
TOPICAL
DOSAGE FORM
SHAMPOO
MARKETING STATUS
Discontinued
Products
NIZORAL · ReferenceDiscontinued
KETOCONAZOLE 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SHAMPOO · TOPICAL
Approval history
2014-01-08Manufacturing (CMC) · Supplement 34 · standardAP
2013-06-05Manufacturing (CMC) · Supplement 33 · standardAP
2002-10-02Manufacturing (CMC) · Supplement 22 · standardAP
2002-05-06Manufacturing (CMC) · Supplement 21 · standardAP
2002-02-28Manufacturing (CMC) · Supplement 20 · standardAP
1999-02-01Manufacturing (CMC) · Supplement 19 · standardAP
1998-05-26Manufacturing (CMC) · Supplement 18 · standardAP
1998-05-26Manufacturing (CMC) · Supplement 16 · standardAP
1998-02-09Manufacturing (CMC) · Supplement 15 · standardAP
1997-10-10Labeling · Supplement 14 · standardAP
1997-05-30Efficacy · Supplement 12 · standardAP
1996-07-09Manufacturing (CMC) · Supplement 13 · standardAP
1996-04-25Labeling · Supplement 11 · standardAP
1996-02-08Manufacturing (CMC) · Supplement 9 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 8 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 6 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 10 · standardAP
1995-10-26Manufacturing (CMC) · Supplement 7 · standardAP
1995-03-06Labeling · Supplement 2AP
1993-10-07Manufacturing (CMC) · Supplement 5 · standardAP
1993-07-02Manufacturing (CMC) · Supplement 4 · standardAP
1992-09-11Manufacturing (CMC) · Supplement 3 · standardAP
1990-10-05Manufacturing (CMC) · Supplement 1 · 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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