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Clinical research / Research / Dopamine agonists / Abbreviated New Drug Application / Bioequivalence / Generic drug / Pergolide / Food and Drug Administration / Drug Price Competition and Patent Term Restoration Act / Pharmacology / Pharmaceutical sciences / Pharmaceutical industry


Public Health Service Food and Drug Administration Rockville MD[removed]NOV[removed]
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Document Date: 2003-02-06 07:12:33

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File Size: 582,20 KB

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Company

Amarin Pharmaceuticals Inc. / Teva Pharmaceuticals / Eli Lilly and Company / D. Amarin Pharmaceuticals Inc. / Ivax Pharmaceuticals / /

Country

United States / /

Currency

pence / USD / /

Event

FDA Phase / /

Facility

Mill Valley / /

IndustryTerm

pharmaceutical equivalence / drug product / treatment of Parkinson’s disease / abbreviated new drug applications / reference products / bioequivalence study protocols / bioequivalent drug products / degradation products / drug products / /

MedicalCondition

Parkinson’s disease / /

Organization

Food and Drug Administration / Center for Drug Evaluation and Research / /

Person

Nicholas M . Fleischer / Michael Wess / /

Position

Director / Orally Administered Drug Products General / /

Product

Permax / pergolide mesylate / in / Permax tablets / /

ProvinceOrState

California / /

Technology

bioequivalence study protocols / /

SocialTag