APPLICATION
ANDA200265
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-12
LATEST ACTION
2022-12-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VORICONAZOLEPrescription
VORICONAZOLE 200MG · TABLET · ORAL
VORICONAZOLEPrescription
VORICONAZOLE 50MG · TABLET · ORAL
Approval history
2022-12-14Labeling · Supplement 21 · standardAP
2022-12-14Labeling · Supplement 20 · standardAP
2022-06-13Labeling · Supplement 19 · standardAP
2022-06-13Labeling · Supplement 17 · standardAP
2022-06-13Labeling · Supplement 15 · standardAP
2022-06-13Labeling · Supplement 18 · standardAP
2022-06-13Labeling · Supplement 16 · standardAP
2019-07-08Labeling · Supplement 12 · standardAP
2019-07-08Labeling · Supplement 10 · standardAP
2015-10-30Labeling · Supplement 9 · standardAP
2015-10-30Labeling · Supplement 8 · standardAP
2011-12-12Not Applicable · OriginalAP
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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