Drug Approval Package
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Abraxane (Pcalitaxel
Protein-Bound Particles) Injectable Suspension
Company: American Biosciences, Inc.
Application No.: 021660
Approval Date: 1/7/2005
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Correspondence (PDF)
Date created: June 162005
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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