APPLICATION
ANDA205034
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-13
LATEST ACTION
2022-06-15
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 200MG/5ML · FOR SUSPENSION · ORAL
Approval history
2022-06-15Labeling · Supplement 7 · standardAP
2022-06-15Labeling · Supplement 5 · standardAP
2022-06-15Labeling · Supplement 3 · standardAP
2022-06-15Labeling · Supplement 13 · standardAP
2022-06-15Labeling · Supplement 11 · standardAP
2022-06-15Labeling · Supplement 6 · standardAP
2022-06-15Labeling · Supplement 12 · standardAP
2022-06-15Labeling · Supplement 10 · standardAP
2016-04-13UNKNOWN · 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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