Drug Approval Package: Lynparza tablets (olaparib)
Company: AstraZeneca Pharmaceuticals LP
Application No.: 208558Orig1s000
Approval Date: August 17, 2017
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- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Multi-Discipline Review/Summary, Clinical, Non-Clinical (PDF)
- Chemistry Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: September 5, 2017
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