FDA.reportPublic FDA data

Application 021464

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VFENDVORICONAZOLETablet; Oral50MGNoNo
002VFENDVORICONAZOLETablet; Oral200MGNoNo
003VFENDVORICONAZOLEInjectable; Injection200MGNoNo

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 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VoriconazoleVORICONAZOLEAmerican Health Packagingc620b2d7-3c2b-4252-8cfc-2f322d6244352026-08-27Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEMeitheal Pharmaceuticals Inc.d962d459-254f-4b78-ae28-7d9ec5d4e4d52026-06-29Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEMylan Pharmaceuticals Inc.b8de04a0-238d-4e0b-b0d9-7f7878b149d42026-06-02Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLESafecor Health LLC23f25c6b-f075-42dc-ae05-63b5bf4109292026-05-28Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEMajor Pharmaceuticals796cad15-2aef-4823-917d-17b822a6916e2026-05-27Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
voriconazoleVORICONAZOLESlate Run Pharmaceuticals7f2e0784-8e48-f565-e053-2991aa0a07462026-05-07Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLESolco Healthcare U.S., LLCf6a1a792-141b-42e8-8bd1-884e4408eb8a2026-04-30Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEAjanta Pharma USA Inc.16a80777-f1f3-45bb-a312-998b07767fe32026-04-24Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLECamber Pharmaceuticals, Inc.fff10d69-e334-42bd-baed-7d9d5feef6aa2026-04-13Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEAurobindo Pharma Limited4fe672ff-2cef-4f88-ab85-5a4b586da20d2026-04-07Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLESandoz Ince648a0e4-f324-49dc-a8f6-cf25ff3b2dfe2026-03-31Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLECivica, Inc.511fa110-e4cc-4498-80db-03b7cddb1d5a2026-03-31Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
voriconazoleVORICONAZOLESandoz Ince2b3c0b3-02a6-45c3-a8ea-05d210dc91082026-03-26Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VFENDVORICONAZOLERoerig08d08721-1f4c-478a-8abf-d9c402d505532026-03-20Warnings, Adverse reactionsName fallback
brand name: VFEND
generic name: VORICONAZOLE
VFENDVORICONAZOLERoerigdac26bcd-7a59-401f-9f66-a0649767cece2026-03-20Warnings, Adverse reactionsName fallback
brand name: VFEND
generic name: VORICONAZOLE
VORICONAZOLEVORICONAZOLEHainan Poly Pharm. Co., Ltd.393a81ba-7d51-450e-8d20-23287767c0022026-03-13Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEFosun Pharma USA Inc.b3b67028-f8a0-4a93-9e73-9e8940c22c4a2026-03-13Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEGland Pharma Limited9d5b9457-ac38-4f17-854d-e394c00e273c2026-03-05Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
voriconazoleVORICONAZOLEMajor Pharmaceuticals49dcf3ae-6d6b-46fe-a88e-ec65f2de332e2026-03-05Warnings, Adverse reactionsName fallback
generic name: VORICONAZOLE
VoriconazoleVORICONAZOLEAmneal Pharmaceuticals LLCed6624a9-0b73-4a21-bf13-a8add2081d022026-03-02Warnings, 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
42181ORIG2005-10-06
37009ORIG2003-12-02
27868ORIG2003-11-25