Application 021466

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VFENDVORICONAZOLETablet; Oral50MGNoNo
002VFENDVORICONAZOLETablet; Oral200MGNoNo
003VFENDVORICONAZOLEInjectable; Iv (Infusion)200MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
voriconazoleVORICONAZOLEViona Pharmaceuticals Inc75fcbea8-8eeb-4528-b7d9-a059dd25da832026-02-26Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
voriconazoleVORICONAZOLEZydus Lifesciences Limitedbda70104-d84b-4d3f-9ca0-5f4f1ca816ad2026-02-26Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VFENDVORICONAZOLERoerigce3ef5cf-3087-4d92-9d94-9eb8287228db2026-02-26Warnings, Adverse reactionsName fallback
brand name: VFEND
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEMylan Pharmaceuticals Inc.67c174da-41b8-4738-8a22-dd814b8e96b82026-02-15Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
voriconazoleVORICONAZOLEBryant Ranch Prepack8217c621-976e-450b-8f48-5dc3119dc53c2025-10-21Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VORICONAZOLEVORICONAZOLELupin Pharmaceuticals,Inc.e37525e8-afb4-4583-b2de-af4aab9040d72025-09-26Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEAmerican Health Packaging8379ac92-53cd-46db-8642-017f11830a862025-09-18Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
voriconazoleVORICONAZOLESlate Run Pharmaceuticals, LLC2b262849-9a29-44a2-9b9d-2378f771379c2025-09-09Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLECamber Pharmaceuticals, Inc.fceb92c5-5269-46e2-ac5f-547b2f77953d2025-09-02Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
voriconazoleVORICONAZOLEGlenmark Pharmaceuticals Inc., USA4cbac6ad-0faa-4181-a830-27a9f1536b7a2025-08-20Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEMylan Institutional Inc.3af8cfe6-1c0d-4b57-ae31-05cffa64132e2025-07-22Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEUBI Pharma Inc.9a81e485-7f26-45b6-bfd7-6114afb7def92025-06-20Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
voriconazoleVORICONAZOLEBryant Ranch Prepack35098192-3bcb-9111-e063-6394a90ae8ea2025-05-13Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLENorthStar Rx LLCb38165a5-d8d4-4579-a49a-fbe92e7640892025-05-02Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
voriconazoleVORICONAZOLEZhejiang Poly Pharm Co., Ltd.3266cf9b-e648-1ff2-e063-6394a90a04872025-04-10Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEAvPAKe698e5c7-f4a5-2beb-e053-2995a90a256b2025-01-09Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
voriconazoleVORICONAZOLEBryant Ranch Prepack711e5a1b-8c40-4b18-9f4f-12c8ab3510122024-08-06Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEEugia US LLC171272c7-d76e-4352-81bc-fcb40386d7d02024-03-05Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEFresenius Kabi USA, LLC25eb8d91-5abd-4fdb-a331-dacc960a95d92024-02-02Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
voriconazoleVORICONAZOLELupin Pharmaceuticals,Inc.b4c934c0-c1bb-4b0a-bc32-fb9e77ef65fc2024-01-31Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42182ORIG2005-11-07
15537ORIG2003-12-08
27869ORIG2003-11-25