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Details for Generic Name: argatroban

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Argatroban is the generic ingredient in five branded drugs marketed by Pfizer, Hikma Pharm Co Ltd, Mylan Institutional, Par Sterile Products, Fresenius Kabi Usa, Teva Pharms Usa, Eagle Pharms, and Sandoz, and is included in nine NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has seven patent family members in five countries.

There are ten drug master file entries for argatroban. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: argatroban

Drug Master File Entries: see list10
Suppliers: see list4
Formulation / Manufacturing:see details

Pharmacology for Ingredient: argatroban

Tentative approvals for ARGATROBAN

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION250MG/250ML
<disabled><disabled>INJECTABLE; INJECTION100MG

Clinical Trials for: argatroban

Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting
Status: Recruiting Condition: CVD

Randomized Controlled Trial of Argatroban With Tissue Plasminogen Activator (tPA) for Acute Stroke
Status: Recruiting Condition: Ischemic Stroke

Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting
Status: Completed Condition: CVD

Argatroban Versus Lepirudin in Critically Ill Patients
Status: Terminated Condition: Heparin Induced Thrombocytopenia (HIT)

Argatroban Stroke Treatment - A Pilot Safety Study
Status: Completed Condition: Ischemic Stroke

Argatroban in Critically Ill Patients With Heparin Resistance
Status: Recruiting Condition: Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin Resistance

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