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Details for Generic Name: argatroban

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

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

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

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eagle Pharms
INJECTABLE;IV (INFUSION)022434Jun 29, 2011RXYes7,687,516<disabled>Y<disabled>
Mylan Institutional
INJECTABLE;INJECTION202626Jun 30, 2014RXNo<disabled><disabled>
SOLUTION;IV (INFUSION)201743May 9, 2011DISCNNo<disabled><disabled>
Eagle Pharms
INJECTABLE;IV (INFUSION)022434Jun 29, 2011RXYes7,589,106<disabled>Y<disabled>
INJECTABLE;INJECTION020883Jun 30, 2000RXYes5,214,052<disabled><disabled>
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