APPLICATION
ANDA206799
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-31
LATEST ACTION
2025-09-30
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 200MG/5ML · FOR SUSPENSION · ORAL
Approval history
2025-09-30Labeling · Supplement 15 · standardAP
2024-05-20Labeling · Supplement 14 · standardAP
2024-02-14Labeling · Supplement 8 · standardAP
2024-02-14Labeling · Supplement 4 · standardAP
2024-02-14Labeling · Supplement 9 · standardAP
2024-02-14Labeling · Supplement 7 · standardAP
2024-02-14Labeling · Supplement 3 · standardAP
2016-05-31UNKNOWN · 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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