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Clinical research / Research / Food and Drug Administration / Abbreviated New Drug Application / Pharmaceuticals policy / Generic drug / New Drug Application / Bioequivalence / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry


Arnall Golden Gregbry UP ‘..,,
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Document Date: 2004-09-17 16:48:59


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File Size: 283,28 KB

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City

Standish Place Rockville / Atlanta / Rockville / Fishers Lane Rockville / One Atlantic Center / /

Company

Arnall Golden Gregory LLP / Page 2 LLP C. / Alan Minsk David Hoffman Arnall Golden Gregory LLP / Shire US Inc. / /

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Event

FDA Phase / /

Facility

One Atlantic Center / /

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IndustryTerm

generic drug product / generic drug products / /

MedicalCondition

frivolous injury / /

Organization

UP Division of Dockets Management / Division of Gastrointestinal / Arnall Golden Gregory Division of Dockets Management / Center for Drug Evaluation and Research Food and Drug Administration Metro Park North / Food and Drug Administration / Gastrointestinal and Coagulation Drug Products office of Drug Evaluation / Director office of Generic Drugs / OVERNIGHT DELIVERY Division / US Federal Reserve / One Atlantic Center Atlanta / Food and Drug Administration Department of Health and Human Services / One Atlantic Center / Macon Office / /

Person

Gary J. Buehler / /

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Position

Counsel / Director / Chief Counsel / Commissioner / /

Product

anagrelide hydrochloride / Agrylin / 2004P-0365 / Citizen Petition / Agrylin capsules / /

ProvinceOrState

Maryland / Georgia / /

URL

www.agg.com / /

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