Composition
- Active ingredients
- OLAPARIB 150MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- OLAPARIB 150MG · TabletANDA217936-002 · Tentative approval
- OLAPARIB 150MG · TabletANDA219410-002 · Tentative approval
- OLAPARIB 150MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA219893.
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
- Olaparib
- Dosage form
- Tablet
- Applicant
- Zydus Pharms USA Inc
- Status
- Tentative approval
- FDA approval
- 6 Nov 2025
- Application
- ANDA219893-002