APPLICATION
ANDA206181
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-24
LATEST ACTION
2025-09-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 200MG · TABLET · ORAL
VORICONAZOLEPrescription
VORICONAZOLE 50MG · TABLET · ORAL
Approval history
2025-09-26Labeling · Supplement 31 · standardAP
2022-11-29Labeling · Supplement 25 · standardAP
2022-11-29Labeling · Supplement 24 · standardAP
2022-06-13Labeling · Supplement 22 · standardAP
2022-06-13Labeling · Supplement 23 · standardAP
2021-07-16Labeling · Supplement 16 · standardAP
2021-07-16Labeling · Supplement 11 · standardAP
2021-07-16Labeling · Supplement 18 · standardAP
2019-07-08Labeling · Supplement 3 · standardAP
2019-07-08Labeling · Supplement 1 · 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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