Drug Approval Package

 Ibuprofen Capsules
Company:  Banner Pharmacaps, Inc.
Application No.:  021472
Approval Date: 10/18/2002

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: November 152004

Back to Top    Drugs@FDA

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