← FDA DRUG APPROVALS

FDA NDA · NDA021630

VFEND

voriconazole

Sponsor: PF PRISM CV

APPLICATION
NDA021630
TYPE
NDA
ORIGINAL APPROVAL
2003-12-19
LATEST ACTION
2026-02-19
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

VFEND · ReferencePrescription
VORICONAZOLE 200MG/5ML · FOR SUSPENSION · ORAL

Approval history

2026-02-19Labeling · Supplement 50 · standard — Letter ↗AP
2026-01-28Labeling · Supplement 49 · standard — Label ↗AP
2025-03-12Labeling · Supplement 47 · standard — Letter ↗AP
2024-08-26Manufacturing (CMC) · Supplement 46 — Letter ↗AP
2022-10-18Labeling · Supplement 42 · standard — Letter ↗AP
2022-08-16Labeling · Supplement 43 · standard — Letter ↗AP
2022-01-28Labeling · Supplement 41 · standard — Letter ↗AP
2021-10-13Labeling · Supplement 40 · standard — Letter ↗AP
2021-04-15Labeling · Supplement 39 · standard — Label ↗AP
2021-01-25Labeling · Supplement 38 · standard — Label ↗AP
2021-01-14Labeling · Supplement 36 · standard — Letter ↗AP
2020-09-04Labeling · Supplement 37 · standard — Label ↗AP
2019-04-30Labeling · Supplement 34 · standard — Label ↗AP
2019-01-29Efficacy · Supplement 29 · priority — Label ↗AP
2018-10-04Labeling · Supplement 33 · standard — Letter ↗AP
2017-07-28Labeling · Supplement 32 · standard — Label ↗AP
2017-06-15Labeling · Supplement 31 · standard — Letter ↗AP
2015-02-03Labeling · Supplement 28 · standard — Letter ↗AP
2014-04-07Labeling · Supplement 27 · standard — Letter ↗AP
2011-11-16Labeling · Supplement 26 · standard — Letter ↗AP
2011-06-01Labeling · Supplement 24 · unknown — Letter ↗AP
2010-12-15Labeling · Supplement 22 · unknown — Label ↗AP
2010-11-21Labeling · Supplement 23 · unknown — Label ↗AP
2010-06-17Labeling · Supplement 21 · unknown — Label ↗AP
2010-06-17Labeling · Supplement 18 · standard — Letter ↗AP
2010-06-17Labeling · Supplement 14 · standard — Label ↗AP
2010-06-17Labeling · Supplement 20 · unknown — Letter ↗AP
2008-05-30Labeling · Supplement 15 · standard — Letter ↗AP
2008-03-10Labeling · Supplement 13 · standard — Label ↗AP
2008-02-05Labeling · Supplement 9 · standard — Label ↗AP
2006-12-01Labeling · Supplement 11 · standard — Label ↗AP
2006-05-19Labeling · Supplement 10 · standard — Label ↗AP
2006-03-10Labeling · Supplement 8 · standard — Letter ↗AP
2005-12-18Labeling · Supplement 6 · standard — Label ↗AP
2005-07-07Labeling · Supplement 5 · standard — Label ↗AP
2005-03-24Labeling · Supplement 4 · standard — Letter ↗AP
2004-12-21Efficacy · Supplement 3 · standard — Label ↗AP
2004-04-21Labeling · Supplement 1 · standard — Review ↗AP
2003-12-19Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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