APPLICATION
ANDA200463
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-20
LATEST ACTION
2019-10-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ITRACONAZOLEDiscontinued
ITRACONAZOLE 100MG · CAPSULE · ORAL
Approval history
2019-10-11Labeling · Supplement 7 · standardAP
2019-10-11Labeling · Supplement 5 · standardAP
2019-10-11Labeling · Supplement 8 · standardAP
2019-10-11Labeling · Supplement 6 · standardAP
2016-05-16Labeling · Supplement 1 · standardAP
2016-05-16Labeling · Supplement 2 · standardAP
2012-07-20Not Applicable · OriginalAP
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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