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Alcohols / Morphinans / Ketones / Opioid antagonists / Pharmacy / Naloxone / Opioid / Drug overdose / Doctor of Pharmacy / Chemistry / Pharmacology / Organic chemistry


CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205787Orig1s000 SUMMARY REVIEW
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Document Date: 2014-04-03 11:13:10

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City

Reference / /

Company

Brodsky / Hertz / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

drug solution / sterile drug product solution / manufacturing date / drug product / listed drug product / drug constituent component manufacturing sites / gray rubber plunger / rubber plungers / /

OperatingSystem

OSE / /

Organization

CDER office of Compliance / CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER / Division of Anesthesia / Analgesia / and Addiction Products / office of Surveillance / Nasal administration / office of Manufacturing / /

Person

Eric Brodsky / Lana Shiu / Keith Marin / Wade Karen Dowdy / Olga Salis / Kellie Taylor / Steven Galati / Review Pharmacology Toxicology / Lynne Yao / Josh Lloyd / Wei Qiu / Morgan Walker / Carlic Huynh / Ron Kaye Chase Bourke / Bryan Riley / R. Daniel Mellon / Wang / Juandria Williams Vicky Borders-Hemphill / William Taylor / Irene Chan / Yun Xu / Hari Sachs / Carl Fischer / Abimbola Adebowale / Sharon Mills / Charles Bonapace / Jessica Cole / Barbara Fuller / Julia Pinto / Erica Wynn / M. Isabel Tejero del Rio / Prasa Peri / Review Sharon Hertz / /

Position

Director 205787 Evzio Division / / /

Product

naloxone / HCI Injection / naloxone HCl / Narcan / Federal Food / Evzio / /

ProvinceOrState

Maryland / /

Technology

pharmacokinetics / /

SocialTag