Drug Approval Package

Amrix (Cyclobenzaprine Hydrochloride) Extended-Release Capsules
Company: ECR Pharmaceuticals
Application No.:  021777
Approval Date: 02/01/2007

• Approval Letter(s) (PDF) 
  

• Approvable Letter (PDF) 

• Printed Labeling (PDF) 
• Medical Review(s) (PDF) 

• Chemistry Review(s) (PDF) 

• Pharmacology Review(s) (PDF) 

• Statistical Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

• Proprietary Name Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF) 

Date created: May 5, 2008

Back to Top    Drugs@FDA

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