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Heparins / Argatroban / Sulfonamides / Chemistry / Anticoagulant / Clinical pharmacology / Thrombocytopenia / Pharmacometrics / Pharmacology / Medicine / Guanidines


Office of Clinical Pharmacology and Biopharmaceutics Review NDA: [removed]SUBMISSION DATE: 29 June 2005 BRAND NAME: Argatroban Injection REVIEWER: Alfredo R. Sancho, Ph.D.
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City

Houston / /

Company

Encysive Pharmaceuticals Inc. / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

drug products / /

MedicalCondition

thrombosis / thrombocytopenia / /

MedicalTreatment

intravenous therapy / /

Organization

OCPB DIVISION / Reviewer Division / Team Leader Division / V office of Clinical Pharmacology / V ORM DIVISION / Agency’s Pediatric Exclusivity Committee / Division Director Division / office of Clinical Pharmacology / /

Person

Mei Huang / Young Moon Choi / Alfredo R. Sancho / Biopharmaceutics Shiew-Mei Huang / Biopharmaceutics Young Moon Choi / Moon Choi / /

Position

TEAM LEADER / /

Product

Argatroban / EXECUTIVE SUMMARY Argatroban Injection / /

ProvinceOrState

Texas / /

Technology

Pharmacokinetics / Medical Imaging / /

SocialTag