FDA.reportPublic FDA data

Application 021948

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERAXISANIDULAFUNGININJECTABLE; INJECTION50MGNoNo

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 1 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERAXISANIDULAFUNGINRoeriga88d9010-55fb-4a02-baff-042cd27688ea2025-08-19Warnings, Adverse reactionsName fallback
brand name: ERAXIS
generic name: ANIDULAFUNGIN
ERAXISANIDULAFUNGINRoerigd138ab10-1ed9-44be-8d81-49dda1e434ac2024-02-19Warnings, Adverse reactionsName fallback
brand name: ERAXIS
generic name: ANIDULAFUNGIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
21883ORIG2006-04-14
28910ORIG2006-03-01
16629ORIG2006-02-28