APPLICATION
ANDA075273
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 20 · standardAP
2020-02-28Labeling · Supplement 18 · standardAP
2017-11-15Labeling · Supplement 16 · standardAP
2017-10-25Labeling · Supplement 14 · standardAP
2017-10-25Labeling · Supplement 15 · standardAP
2001-09-05Manufacturing (CMC) · Supplement 2AP
2001-08-30Manufacturing (CMC) · Supplement 3AP
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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