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Food and Drug Administration / Clinical research / Pharmaceuticals policy / Pharmaceutical industry / Abbreviated New Drug Application / New Drug Application / Federal Food / Drug / and Cosmetic Act / Ondansetron / Bioequivalence / Pharmaceutical sciences / Pharmacology / Medicine


OL~~ON, PHILIP C. OLSSON RICHARD L. FRANK DAVID E WEEDA[removed]DENNIS R JOHNSON ARTHUR ‘r: TSIEN
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Document Date: 2004-12-27 14:08:29

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City

Rockville / /

Company

TestoCremeLLC / Apotex Inc. / Shotwell & Carr Inc. / GlaxoSmithKline / Gensia Sicor Pharmaceuticals Inc. / Wallace Laboratories / PharmaceuticalAssociatesInc. / Abbott Laboratories / MedPointe Pharmaceuticals / /

Event

FDA Phase / Product Recall / Product Issues / /

IndustryTerm

injectable drug products / injectable drug product / 4mg/8mL product / drug product / reference product / proposed drug product / 2mg/ml product / separatedrug products / drug products / 2mg/4mL product / /

MedicalCondition

severe hepatic failure / nauseaand vomiting / chemotherapy-inducednauseaand vomiting / /

MedicalTreatment

chemotherapy / /

Organization

Food and Drug Administration / Food and Drug Administration Department of Health and Human Services / /

Person

JOHN W. BODE / FLAHERTY DAVID / LACEY EVAN / DENNIS R JOHNSON / NAOMI J. L. HALPERN STEPHEN / MARSHALL L. MATZ / VALERIE B. SOLOMON / ROBERT A. HAHN NAOMI / DAVID L. DURKIN NEIL / JOHNSON ARTHUR / BRETT T. SCHWEMER FRANKAND ATTORNEYS WEEDA / FLAHERTY PAMELA / TISH E. PAHL ROBERT / PHILIP C. OLSSON RICHARD / STEPHEN L LACEY / STEPHEN D. TERMAN MARSHALL / Arthur Y. Tsien / RICHARD L. FRANK / L. FRANK DAVID E WEEDA / E. JOHNSON SALLY / PAMELA J. FURMAN BRETT / KENNETH D. ACKERMAN / /

/

Position

GOVERNM@3TAFFAlRS ADVISOR / COUNSEL / Commissioner / /

Product

mesna / carisoprodol / petition / Soma / ifosfamide / 350mg / 200mg / ZOFRAN / ondansetron hydrochloride / 2004P-0048 / ZOFRAN injection / /

ProvinceOrState

Maryland / /

Technology

chemotherapy / /

URL

www.zof&n.com / /

SocialTag