Drug Approval Package

Arestin (Minocycline Hydrochloride) Microspheres
Company:  OraPharma, Inc.
Application No.:  50-781
Approval Date: 2/16/01

• Approval Letter(s) (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  
  Part 5 (PDF)  
  Part 6 (PDF)  
  Part 7 (PDF)  
  Part 8 (PDF)  
  Part 9 (PDF)  
  Part 10 (PDF)  
  Part 11 (PDF)

Date created: February 20, 2003

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