APPLICATION
ANDA216805
TYPE
ANDA
ORIGINAL APPROVAL
2024-01-02
LATEST ACTION
2025-08-25
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 200MG/5ML · FOR SUSPENSION · ORAL
Approval history
2025-08-25Labeling · Supplement 1 · standardAP
2024-01-02UNKNOWN · 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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