APPLICATION
ANDA091658
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-06
LATEST ACTION
2025-07-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
VORICONAZOLEDiscontinued
VORICONAZOLE 50MG · TABLET · ORAL
VORICONAZOLEDiscontinued
VORICONAZOLE 200MG · TABLET · ORAL
Approval history
2025-07-23Labeling · Supplement 8 · standardAP
2025-07-23Labeling · Supplement 11 · standardAP
2025-07-23Labeling · Supplement 7 · standardAP
2025-07-23Labeling · Supplement 5 · standardAP
2016-01-21Labeling · Supplement 1 · standardAP
2016-01-21Labeling · Supplement 2 · standardAP
2012-04-06OriginalAP
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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