APPLICATION
ANDA207371
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-24
LATEST ACTION
2024-09-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 200MG · TABLET · ORAL
VORICONAZOLEPrescription
VORICONAZOLE 50MG · TABLET · ORAL
Approval history
2024-09-25Labeling · Supplement 9 · standardAP
2024-09-25Labeling · Supplement 11 · standardAP
2024-09-25Labeling · Supplement 10 · standardAP
2024-08-26Labeling · Supplement 5 · standardAP
2024-08-26Labeling · Supplement 8 · standardAP
2024-08-26Labeling · Supplement 6 · standardAP
2016-05-24UNKNOWN · 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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