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Pancreas / Metformin / Diabetes mellitus / Biguanide / Phenformin / Insulin resistance / Insulin-dependent diabetes mellitus / Glibenclamide / Glycated hemoglobin / Diabetes / Endocrine system / Endocrinology


Medical Officer Safety Review of an Original NDA Submission NDAMetformin rev 2.1
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Document Date: 2006-08-23 00:32:00

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File Size: 666,20 KB

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City

Harris / Scrimshaw / /

Company

Weaver SA / GE / Pinault / HP / National Diabetes Data Group / Lipha Pharmaceuticals / /

Continent

America / /

Country

Germany / United States / /

Event

FDA Phase / /

Facility

National Center / Port FK / Taubman G. Arch / Laboratory Abnormalities / /

IndustryTerm

aqueous solution / /

MedicalCondition

hyperinsulinemia / insulin-dependent diabetes mellitus / JE / America /

Organization

World Health Organization / 3Medical Officer Safety Review Hochschule in Hannover / Medicare / Department of Biochemistry / US Federal Reserve / National Center for Health Statistics / /

Person

Safety Review / David Hertig / Günter Schäfer / Xavier Ysern / John Hunt / Dan Gordin / Safety Review Is / /

Position

Stern MP / Biopharmaceutical Officer / operative / Officer / King / Medical Officer / Chemistry Officer / Pharmacology Officer / 7Medical Officer / 4Medical Officer / 2Medical Officer / 5Medical Officer / 8Medical Officer / /

Product

guanidine hydrochloride / cimetidine / Metformin / metformin hydrochloride / 1Medical Officer Safety Review Drug / /

ProvinceOrState

Michigan / Nova Scotia / /

PublishedMedium

the Pharmacology Officer Review / /

Region

southeastern Michigan / /

Technology

GPS / Pharmacokinetics / /

SocialTag