Drug Approval Package: Readi-Cat 2 Smoothie Oral Suspension 2% (w/v) (Barium sulfate)
Company: Bracco Diagnostics Inc.
Application No.: 208143Orig1s000
Approval Date: January 15, 2016
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- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Office Director Memo (PDF)
- Cross Discipline Team Leader Review (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (PDF)
- Microbiology 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 9, 2016
Updated: August 10, 2018
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