Drug Approval Package
Velosulin
BR (Human Buffered Regular Insulin (rDNA origin)) Injection
Company: Novo Nordisk Pharmaceuticals, Inc.
Application No.: 021-028
Approval Date: 7/19/1999
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Approval Letter(s) (PDF) (618 KB)
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Final Printed Labeling & Medical Review(s) (PDF) (2.4 MB)
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Chemistry Review(s) & Statistical Review(s) (PDF) (1.7 MB)
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Microbiology Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.4 MB)
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Administrative Document(s)/Correspondence
Part 1 (PDF) (2.5 MB)
Part 2 (PDF) (2.8 MB)
Date created: March 30, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.