FDA
Osimertinib Mesylate
The FDA lists this product in 2 strengths and forms.
Composition
- Active ingredients
- OSIMERTINIB MESYLATE 80MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- OSIMERTINIB MESYLATE 80MG · TabletThis page
- OSIMERTINIB MESYLATE 40MG · TabletANDA214263-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA214263.
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
- Osimertinib Mesylate
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Zydus Pharms USA Inc
- Status
- Tentative approval
- FDA approval
- 1 Jun 2021
- Application
- ANDA214263-002