argatroban

FDA Drug Profile — Argatroban

argatroban is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Argatroban. Available dosage form: injection, solution.

Drug Details

Generic Name
argatroban
Brand Names
Argatroban
Application Number
ANDA202626
Sponsor
Mylan Institutional LLC
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
ARGATROBAN

Indications and Usage

1 INDICATIONS AND USAGE Argatroban is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) ( 1.1 ) As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) ( 1.2 ) 1.1 Heparin-Induced Thrombocytopenia Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.2 Percutaneous Coronary Intervention Argatroban Injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).