Drug Approval Package

Suclear (sodium sulfate, potassium sulfate, and magnesium sulfate oral solution
and PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride powder for oral
solution)
Company:  Braintree Laboratories, Inc.
Application No.:  203595
Approval Date: 1/18/2013

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• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: January 24, 2014

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