FDA Application

Ipratropium
Company: Zenith Goldline Pharmaceuticals
Application No.: 075313
Approval Date: 02/07/2000

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Bioequivalence Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)  

Date created: August 4, 2003

Back to Top    Drugs@FDA

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