Cross-discipline team leader review: NDA 208418: calcium gluconate injection | Health & Environmental Research Online (HERO)

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Citation
Tags

HERO ID

4940077

Reference Type

Technical Report

Title

Cross-discipline team leader review: NDA 208418: calcium gluconate injection

Author(s)

Zemskova, M

Year

2017

Report Number

NDA 208418

Number of Pages

Language

English

URL

https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM568985.pdf
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Abstract

On May 16, 2016 Fresenius Kabi submitted a New Drng Application (NDA) for Calcium
Gluconate Injection under Section 505(b) (2) of the Federal Food, Drug, and Cosmetic Act.