Drug Approval Package
Neotect
50ug Peptide (Kit for Technetium Tc99m Depreotide) Injection
Company: Diatide Inc.
Application No.: 021012
Approval Date: 8/3/1999
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Approval Letter(s) (PDF) (1.4 MB)
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Final Printed Labeling (PDF) (1.2 MB)
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Medical Review(s)
Part 1 (PDF) (2.9 MB)
Part 5 (PDF) (2.9 MB) Part 9 (PDF) (2.1 MB) Part 2 (PDF) (3 MB) Part 6 (PDF) (2.9 MB) Part 10 (PDF) (1.8 MB) Part 3 (PDF) (3 MB) Part 7 (PDF) (2.3 MB) Part 4 (PDF) (3 MB) Part 8 (PDF) (2.5 MB) -
Chemistry Review(s) (PDF) (593 KB)
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Pharmacology Review(s)
Part 1 (PDF) (2.2 MB)
Part 2 (PDF) (2.1 MB)
Part 3 (PDF) (2.5 MB) -
Statistical Review(s) & Microbiology Review(s) (PDF) (2.4 MB)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (3 MB)
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Administrative Document(s)/Correspondence (PDF) (1.8 MB)
Date created: March 30, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.