Drug Approval Package

 Bidil (Isosorbide Dinitrate and Hydralazine Hydrochloride) Tablets
Company:  NitroMed, Inc.
Application No.:  020727
Approval Date: 06/23/2005

• Approval Letter(s) (PDF)

• Approvable 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: June 212006

Back to Top    Drugs@FDA

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