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FDA NDA · NDA208562

VORICONAZOLE

Sponsor: HIKMA

APPLICATION
NDA208562
TYPE
NDA
ORIGINAL APPROVAL
2017-03-09
LATEST ACTION
2025-04-18
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
POWDER, INJECTABLE
MARKETING STATUS
Prescription

Products

VORICONAZOLEPrescription
VORICONAZOLE 200MG/VIAL · POWDER · INTRAVENOUS
VORICONAZOLEPrescription
VORICONAZOLE 200MG · INJECTABLE · INJECTION

Approval history

2025-04-18Labeling · Supplement 11 · standard — Label ↗AP
2023-01-03Labeling · Supplement 5 · standard — Letter ↗AP
2022-08-16Labeling · Supplement 6 · standard — Letter ↗AP
2021-12-17Labeling · Supplement 4 · standard — Label ↗AP
2018-03-26Labeling · Supplement 2 · standard — Label ↗AP
2017-03-09Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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