Drug Approval Package

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Drug Approval Package

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Azithomycin
Citrate for Injection 500 mg/vial and 2.5g1vial
Company: Sicor Pharaceuticals, Inc.
NDA: 050809
Approval Date: 12/19/2006

Approvable Letter(s) (PDF)
Approval Letter(s) (PDF)
Printed Labeling (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Microbiology Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Administrative Document(s) and Correspondence (PDF)

Date created: October 3, 2008

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