Drug Approval Package

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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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