APPLICATION
NDA018533
TYPE
NDA
ORIGINAL APPROVAL
1981-06-12
LATEST ACTION
2014-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NIZORAL · ReferenceDiscontinued
KETOCONAZOLE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-08-13Manufacturing (CMC) · Supplement 39 · priorityAP
2002-04-01Manufacturing (CMC) · Supplement 38 · priorityAP
1999-09-17Manufacturing (CMC) · Supplement 37 · priorityAP
1999-04-13Manufacturing (CMC) · Supplement 36 · priorityAP
1998-07-24Manufacturing (CMC) · Supplement 35 · priorityAP
1998-05-28Manufacturing (CMC) · Supplement 33 · priorityAP
1998-03-17Manufacturing (CMC) · Supplement 32 · priorityAP
1996-07-08Labeling · Supplement 29 · priorityAP
1996-06-14Manufacturing (CMC) · Supplement 31 · priorityAP
1996-04-08Manufacturing (CMC) · Supplement 30 · priorityAP
1995-09-15Manufacturing (CMC) · Supplement 28 · priorityAP
1995-09-08Manufacturing (CMC) · Supplement 26 · priorityAP
1995-09-08Manufacturing (CMC) · Supplement 25 · priorityAP
1994-03-22Labeling · Supplement 24 · priorityAP
1993-09-20Manufacturing (CMC) · Supplement 23 · priorityAP
1992-12-28Labeling · Supplement 22 · priorityAP
1992-12-28Labeling · Supplement 20 · priorityAP
1992-10-13Manufacturing (CMC) · Supplement 21 · priorityAP
1991-03-15Labeling · Supplement 19 · priorityAP
1989-04-14Labeling · Supplement 18 · priorityAP
1988-07-08Manufacturing (CMC) · Supplement 17 · priorityAP
1988-05-10Manufacturing (CMC) · Supplement 16 · priorityAP
1986-06-30Labeling · Supplement 3 · priorityAP
1986-06-30Labeling · Supplement 14 · priorityAP
1986-06-30Labeling · Supplement 12 · priorityAP
1986-06-30Labeling · Supplement 13 · priorityAP
1986-06-30Labeling · Supplement 11 · priorityAP
1985-06-19Manufacturing (CMC) · Supplement 15 · priorityAP
1984-07-09Manufacturing (CMC) · Supplement 10 · priorityAP
1984-07-09Manufacturing (CMC) · Supplement 9 · priorityAP
1983-09-08Manufacturing (CMC) · Supplement 8 · priorityAP
1983-06-23Labeling · Supplement 4 · priorityAP
1983-06-23Labeling · Supplement 2 · priorityAP
1983-04-15Manufacturing (CMC) · Supplement 6 · priorityAP
1983-04-15Manufacturing (CMC) · Supplement 7 · priorityAP
1981-09-29Manufacturing (CMC) · Supplement 1 · priorityAP
1981-06-12Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗AP
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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