Composition
- Active ingredients
- PEMIGATINIB 4.5MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- PEMIGATINIB 9MG · TabletANDA219552-003 · Tentative approval
- PEMIGATINIB 4.5MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA219552.
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
- Pemigatinib
- Dosage form
- Tablet
- Applicant
- Sandoz Inc
- Status
- Tentative approval
- FDA approval
- 1 Jun 2026
- Application
- ANDA219552-002