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Organic chemistry / Clinical research / Pharmaceutical industry / Drug safety / Lactams / Tamsulosin / New Drug Application / Structured Product Labeling / Dutasteride / Chemistry / Food and Drug Administration / Medicine


CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for:
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Document Date: 2011-02-03 14:44:20

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File Size: 74,97 KB

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Company

SMITHKLINE DUTASTERIDE/ TAMSULOSIN BEECHAM CORP / GlaxoSmithKline LLC / NDA APPROVAL GlaxoSmithKline LLC / /

Event

FDA Phase / /

IndustryTerm

proposed introductory advertising / /

MedicalCondition

BPH / benign prostatic hyperplasia / /

Organization

Reproductive and Urologic Products Office / Food and Drug Administration / CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package / Division of Reproductive / Food and Drug Administration Center for Drug Evaluation / CENTER FOR DRUG EVALUATION AND RESEARCH / DEPARTMENT OF HEALTH AND HUMAN SERVICES / Center for Drug Evaluation and Research Division of Drug Marketing / Advertising / and Communications / Labeling REMS Summary Review Officer/Employee List Office / /

Person

Memo Cross / Silver Spring / Antiviral / GEORGE S BENSON / Sherman N. Alfors / George Benson / Olga Salis / /

/

Position

Deputy Director / Director / Regulatory Project Manager / /

Product

Tamsulosin hydrochloride / tamsulosin / Jalyn™ / CM072392 / Jalyn / 022460Orig1s000 / /

ProvinceOrState

Maryland / North Carolina / /

Technology

alpha / pdf / /

URL

http /

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