Drug Approval Package

 Oraqix (Lidocaine and Prilocaine) Periodontal Gel
Company: Dentsply Pharmaceutical
Application No.:  021451
Approval Date: 12/19/2003

• Approval Letter(s) (PDF)  

• Printed Labeling (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 (PDF)  

Date created: September 062006

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