Drug Approval Package

 HalfLytely and Bisacodyl Tablets (Bowel Prep)
Company: Brantree Laboratories, Inc. 
Application No.:  021551
Approval Date: 5/10/2004

• Approval Letter(s) (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) 

• Administrative Document(s) & Correspondence (PDF)  

Date created: December 01, 2005, updated April 27, 2007

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