Drug Approval Package
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Drug Name: Lybrel (levonorgestrel and ethinyl estradiol)
Company: Wyeth Pharmaceuticals
NDA: 021864
Approval Date: 5/22/2007
- Approvable Letter(s) (PDF)
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Office Director Memo (PDF)
- Cross Discipline Team Leader Review (PDF)
- Medical Review(s)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Administrative Document(s) and Correspondence (PDF)
Date created: December 22, 2008
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