Drug Approval Package

Nicorette (Nicotine Polacrilex Gum) 2mg & 4mg
Company:  SmithKline Beecham Consumer Healthcare
Application No.:  18-612/S25 & 20-066/S7
Approval Date: 12/23/1998

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

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

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)

Date created: May 01, 2002

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.