Drug Approval Package

 Norditropin (Somatropin [rDNA origin] Injection)
Company:  Novo NordiskPharmaceuticals, Inc.
Application No.:  021148
Approval Date: 6/20/2000

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) (PDF)

• Correspondence (PDF)  

Date created: June 142004

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