APPLICATION
ANDA090547
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-22
LATEST ACTION
2025-10-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 200MG · TABLET · ORAL
VORICONAZOLEPrescription
VORICONAZOLE 50MG · TABLET · ORAL
Approval history
2025-10-23Labeling · Supplement 19 · standardAP
2023-09-11Labeling · Supplement 9 · standardAP
2023-09-11Labeling · Supplement 15 · standardAP
2023-09-11Labeling · Supplement 13 · standardAP
2023-09-11Labeling · Supplement 11 · standardAP
2023-09-11Labeling · Supplement 8 · standardAP
2023-09-11Labeling · Supplement 18 · standardAP
2023-09-11Labeling · Supplement 16 · standardAP
2023-09-11Labeling · Supplement 12 · standardAP
2023-09-11Labeling · Supplement 10 · standardAP
2016-01-12Labeling · Supplement 5 · standardAP
2016-01-12Labeling · Supplement 6 · standardAP
2013-03-27Labeling · Supplement 2AP
2011-03-09Labeling · 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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