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Food and Drug Administration / Pharmaceutical industry / Pharmaceuticals policy / Abbreviated New Drug Application / New Drug Application / Generic drug / Amiodarone / Federal Food / Drug / and Cosmetic Act / IntelliPharmaCeutics / Chemistry / Medicine / Pharmaceutical sciences


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857
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Document Date: 2003-02-06 07:12:35

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File Size: 126,22 KB

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City

Rockville / /

Company

Wyeth / Research Institute Ltd. / CP 1 Taro Research Institute Ltd. / /

Currency

pence / /

Event

FDA Phase / /

IndustryTerm

listed reference drug product / drug product / above-referenced drug product / proposed drug product / listed drug product / /

Organization

office of Generic Drugs / Food and Drug Administration / DEPARTMENT OF HEALTH / Division of Bioequivalence / office of Generic Drugs Center for Drug Evaluation and Research / /

Person

Gary J. Bue / Avraham Yacobi / /

Position

ler Director / /

Product

Cordarone / Amiodarone Hydrochloride / Amiodarone Hydrochloride Tablets / 1S-972 / /

ProvinceOrState

Maryland / New York / /

SocialTag