APPLICATION
ANDA203503
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-02
LATEST ACTION
2025-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 50MG · TABLET · ORAL
VORICONAZOLEPrescription
VORICONAZOLE 200MG · TABLET · ORAL
Approval history
2025-09-16Labeling · Supplement 13 · standardAP
2022-11-29Labeling · Supplement 11 · standardAP
2022-11-29Labeling · Supplement 10 · standardAP
2022-06-13Labeling · Supplement 9 · standardAP
2022-06-13Labeling · Supplement 7 · standardAP
2022-06-13Labeling · Supplement 5 · standardAP
2022-06-13Labeling · Supplement 8 · standardAP
2022-06-13Labeling · Supplement 6 · standardAP
2019-06-28Labeling · Supplement 2 · standardAP
2019-06-28Labeling · Supplement 3 · standardAP
2019-06-28Labeling · Supplement 1 · standardAP
2015-09-02UNKNOWN · 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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