Drug Approval Package

Altace (Ramipril) Tablets
Company: Cobalt Pharmaceuticals Inc.
Application No.:  022021
Approval Date: 02/27/2007

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: March 14, 2008

Back to Top    Drugs@FDA

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