Drug Approval Package

 Lyrica (Pregabalin) Capsules
Company:  Pfizer Global Research and Development
Application No.:  021723
Approval Date: 12/30/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)

• Environmental Assessment (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: December 022005

Back to Top    Drugs@FDA

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