FDA.reportPublic FDA data

Application 210804

Type
ANDA
Sponsor
MSN PHARMACEUTICALS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AFATINIBAFATINIBTABLET;ORAL20MGNoNo
002AFATINIBAFATINIBTABLET;ORAL30MGNoNo
003AFATINIBAFATINIBTABLET;ORAL40MGNoNo

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
AfatinibAFATINIBCamber Pharmaceuticals, Inc.ec5b9e00-3eab-4dbd-9bb3-75865b1af4852026-09-03Warnings, Adverse reactionsName fallback
brand name: Afatinib
generic name: AFATINIB
GilotrifAFATINIBBoehringer Ingelheim Pharmaceuticals, Inc.fd638e5e-8032-e7ca-0179-95e96ab5d3872025-11-13Warnings, Adverse reactionsName fallback
generic name: AFATINIB

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73763ORIG 2026-03-19