Drug Approval Package
MiraLax (Polyethylene Glycol 3350) Powder
Company: Braintree Laboratories, Inc.
Application No.: 20-698
Approval Date: 2/18/1999
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Approval Letter & Printed Labeling (PDF) (919 KB)
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Medical Review(s)
Part 1 (PDF) (2.6 MB)
Part 2 (PDF) (2.8 MB)
Part 3 (PDF) (2 MB) -
Chemistry Review(s) & Pharmacology Review(s) (PDF) (1.6 MB)
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Statistical Review(s)
Part 1 (PDF) (2.5 MB)
Part 2 (PDF) (1.4 MB)
Part 3 (PDF) (2.6 MB) -
Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (929 KB)
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Administrative Document(s)/Correspondence
Part 1 (PDF) (2.3 MB)
Part 2 (PDF) (2.1 MB)
Part 3 (PDF) (2 MB)
Date created: March 30, 2001; last update: July 5, 2005
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