FDA.reportPublic FDA data

Application 218578

Type
ANDA
Sponsor
NATCO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERDAFITINIBERDAFITINIBTABLETNoNo

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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BALVERSAERDAFITINIBJanssen Products LP2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee2025-10-24Warnings, Adverse reactionsName fallback
generic name: ERDAFITINIB

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85428ORIG 2026-03-20
85427ORIG 2026-03-20