`RESEARCH
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`APPLICATION NUMBER:
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`205029Orig1s000
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`PROPRIETARY NAME REVIEW(S)
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`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`Office of Medication Error Prevention and Risk Management
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`Proprietary Name Review
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`April 2, 2013
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`Date:
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`Reviewer:
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`Team Leader:
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`Deputy Director:
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`Drug Name and Strength(s):
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`Application Type/Number:
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`Applicant/Sponsor:
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`OSE RCM #:
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`*** This document contains proprietary and confidential information that should not be
`released to the public.***
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`Kimberly DeFronzo, RPh, MS, MBA
`Division of Medication Error Prevention and Analysis
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`Irene Z. Chan, PharmD, BCPS
`Division of Medication Error Prevention and Analysis
`Kellie Taylor, PharmD, MPH
`Division of Medication Error Prevention and Analysis
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` (Epinephrine Injection, USP) 1:1000 (1 mg/mL)
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`NDA 205029
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`Belcher Pharmaceuticals, LLC
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`2013-45
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`Reference ID: 3286902
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`(b) (4)
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`33 Pages have been Withheld in Full as b4 (CCI/TS) immediately
`following this page.
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`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
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`/s/
`----------------------------------------------------
`KIMBERLY A DE FRONZO
`04/02/2013
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`IRENE Z CHAN
`04/03/2013
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`KELLIE A TAYLOR
`04/03/2013
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`Reference ID: 3286902
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`