APPLICATION
ANDA214516
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-09
LATEST ACTION
2025-09-30
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 200MG/VIAL · POWDER · INTRAVENOUS
Approval history
2025-09-30Labeling · Supplement 4 · standardAP
2023-02-02Labeling · Supplement 1 · standardAP
2023-02-02Labeling · Supplement 2 · standardAP
2022-05-09UNKNOWN · 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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