Application 021464

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VFEND	VORICONAZOLE	Tablet; Oral	50MG	No	No
002	VFEND	VORICONAZOLE	Tablet; Oral	200MG	No	No
003	VFEND	VORICONAZOLE	Injectable; Injection	200MG	No	No

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 3 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VORICONAZOLE	VORICONAZOLE	Novel Laboratories, Inc.	53ecce53-57b8-4af1-b4ac-7d37eb25711f	2023-12-05	Warnings, Adverse reactions	Name fallback generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Xellia Pharmaceuticals USA LLC	9ec6eda2-2f15-423b-9ec6-819379a426e1	2023-01-11	Warnings, Adverse reactions	Name 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
Document	Submission type	Date
42181	ORIG	2005-10-06
37009	ORIG	2003-12-02
27868	ORIG	2003-11-25