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

Zemskova, M

HERO ID

4940077

Reference Type

Technical Report

Year

2017

Language

English

HERO ID 4940077
Year 2017
Title Cross-discipline team leader review: NDA 208418: calcium gluconate injection
Authors Zemskova, M
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.
Report Number NDA 208418
Url https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM568985.pdf
Is Certified Translation No
Dupe Override No
Number Of Pages 19
Comments Sensitive information has been redacted.
Is Public Yes
Language Text English