Drug Approval Package
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Fludarabine Phosphate Injection
Company: Ebewe Pharma Ges.m.b.H. Nfg.KG
NDA: 022137
Approval Date: 9/21/2007
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Chemistry Review(s) (PDF)
- Microbiology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Administrative Document(s) and Correspondence (PDF)
Date created: November 17, 2008
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