Drug Approval Package
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Venofer
(Iron Sucrose) Injection
Company: Luitpold Pharmaceuticals, Inc.
Application No.: 21135
Approval Date: 11/7/00
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Approval Letter(s)(PDF)
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Printed Labeling(PDF)
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Medical Review(s)
Part 1(PDF) Part 2(PDF) Part 3(PDF) Part 4(PDF) -
Chemistry Review(s)(PDF)
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Pharmacology Review(s)
Part 1(PDF) Part 2(PDF) -
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Part 1(PDF)
Part 2(PDF) -
Correspondence(PDF)
Date created: June 07, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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