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Kabiven and Perikabiven (amino acids, electrolytes, dextrose and lipid) injectable emulsion

Kabiven and Perikabiven

Company: Fresenius Kabi USA, LLC
Application No.: 200656
Approval Date: 08/25/2014

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Approval Letter(s) (PDF)
Other Action Letter (s) (PDF)
Printed Labeling (PDF)
Summary Review (PDF)
Officer/Employee List (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: February 29, 2016; updated 10/25/2016

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