APPLICATION
ANDA075362
TYPE
ANDA
ORIGINAL APPROVAL
1999-06-15
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
KETOCONAZOLEDiscontinued
KETOCONAZOLE 200MG · TABLET · ORAL
Approval history
2023-08-16Labeling · Supplement 14 · standardAP
2020-02-28Labeling · Supplement 13 · standardAP
2017-11-15Labeling · Supplement 11 · standardAP
2017-11-03Labeling · Supplement 12 · standardAP
2001-09-20Manufacturing (CMC) · Supplement 2AP
2000-07-07Manufacturing (CMC) · Supplement 1AP
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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