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Ketones / Alcohols / Hydrocodone / Euphoriants / Opioid / Food and Drug Administration / New Drug Application / Kappa Opioid receptor / Chemistry / Organic chemistry / Morphinans


Zohydro ER (hydrocodone bitartrate) extended-release capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg.
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Document Date: 2013-10-25 12:06:05

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File Size: 167,81 KB

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City

Emeryville / Reference / /

Company

NDA APPROVAL Zogenix Inc. / RAC / /

Event

FDA Phase / Product Issues / /

IndustryTerm

train healthcare providers / biological product applications / healthcare providers / opioid products / adequate protocols / /

MedicalCondition

hyperalgesia following use / chronic abusers / hyperalgesia / chronic pain / psychiatric illness / pain / /

Organization

FDA / Accreditation Council for Continuing Medication Education / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring / /

Person

Silver Spring / Edward F. Smith / /

Position

Vice President / Regulatory Affairs and Product Quality/Safety Dear Dr. Smith / Vice President / Regulatory Affairs and Product Quality/Safety Dear / /

Product

Continuing Medication / ICD10 / approved drug / Zohydro ER (hydrocodone bitartrate) extended-release capsules / alternative treatment options / CM072392 / /

ProvinceOrState

Maryland / California / /

PublishedMedium

The Medication Guide / /

Technology

3395199 Protocol / pdf / /

URL

http /

SocialTag