Composition
- Active ingredients
- AFATINIB 40MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- AFATINIB 40MG · TabletANDA210703-004 · Tentative approval
- AFATINIB 30MG · TabletANDA210703-002 · Tentative approval
- AFATINIB 20MG · TabletANDA210703-003 · Tentative approval
- AFATINIB 40MG · TabletThis page
- AFATINIB 20MG · TabletANDA210804-001 · Tentative approval
- AFATINIB 30MG · TabletANDA210804-002 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA210804.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Afatinib
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- MSN Pharmaceuticals Inc
- Status
- Tentative approval
- FDA approval
- 18 Feb 2026
- Application
- ANDA210804-003