Home Applications 210804 Application 210804
Type ANDA
Sponsor MSN PHARMACEUTICALS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AFATINIB AFATINIB TABLET;ORAL 20MG No No 002 AFATINIB AFATINIB TABLET;ORAL 30MG No No 003 AFATINIB AFATINIB TABLET;ORAL 40MG 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 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gilotrif AFATINIB Boehringer Ingelheim Pharmaceuticals, Inc. fd638e5e-8032-e7ca-0179-95e96ab5d387 2025-11-13 Warnings, Adverse reactions Name fallback generic name: AFATINIB
Documents# Document, Submission type, Date table Document Submission type Date 73763 ORIG 2026-03-19