ColPrep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) for oral solution
Company: Gator Pharmaceuticals, Inc.
Application No.: 204553
Approval Date: 12/27/2016
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- 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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