Drug Approval Package
Natrecor
(Nesiritide) Injection
Company: Scios Inc.
Application No.: 20-920
Approval Date: 8/10/2001
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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 5 (PDF) Part 9 (PDF) Part 2 (PDF) Part 6 (PDF) Part 10 (PDF) Part 3 (PDF) Part 7 (PDF) Part 11 (PDF) Part 4 (PDF) Part 8 (PDF) -
Chemistry Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
Part 6 (PDF)
Part 7 (PDF) -
Correspondence (PDF)
Date created: April 04, 2002
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