APPLICATION
ANDA090862
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-30
LATEST ACTION
2025-08-05
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 200MG/VIAL · POWDER · INTRAVENOUS
Approval history
2025-08-05Labeling · Supplement 22 · standardAP
2023-04-28Labeling · Supplement 16 · standardAP
2023-04-28Labeling · Supplement 19 · standardAP
2023-04-28Labeling · Supplement 15 · standardAP
2023-04-28Labeling · Supplement 21 · standardAP
2021-06-22Labeling · Supplement 8 · standardAP
2021-06-22Labeling · Supplement 12 · standardAP
2021-06-22Labeling · Supplement 10 · standardAP
2021-06-22Labeling · Supplement 9 · standardAP
2021-06-22Labeling · Supplement 13 · standardAP
2021-06-22Labeling · Supplement 11 · standardAP
2015-10-23Labeling · Supplement 2 · standardAP
2015-10-23Labeling · Supplement 1 · standardAP
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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