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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