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ColPrep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) for oral solution

ColPrep Kit

Company: Gator Pharmaceuticals, Inc.
Application No.: 204553
Approval Date: 12/27/2016

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Approval Letter(s) (PDF)
Other Action Letters (PDF)
Printed Labeling (PDF)
Summary Review (PDF)
Officer/Employee List (PDF)
Chemistry Review(s) (PDF)
Pharmacology 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: November 21, 2017

Updated: March 15, 2018

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