APPLICATION
ANDA211099
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-31
LATEST ACTION
2025-07-23
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 200MG/VIAL · POWDER · INTRAVENOUS
Approval history
2025-07-23Labeling · Supplement 12 · standardAP
2022-12-13Labeling · Supplement 9 · standardAP
2022-12-13Labeling · Supplement 10 · standardAP
2022-06-06Labeling · Supplement 7 · standardAP
2022-06-06Labeling · Supplement 1 · standardAP
2022-06-06Labeling · Supplement 8 · standardAP
2022-06-06Labeling · Supplement 4 · standardAP
2022-06-06Labeling · Supplement 2 · standardAP
2020-03-31UNKNOWN · Original · 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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