Direct thrombin inhibitors

Bivalirudin

Approved 27 Jul 2018IntravenousInjectable

The FDA lists this product in 13 strengths and forms.

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Composition

Active ingredients: BIVALIRUDIN 250MG/VIAL

Strengths and forms

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ANDA204876-001 · Discontinued

BIVALIRUDIN 250MG/VIAL · InjectableANDA090811-001 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA205962.

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At a glance

Brand name: Bivalirudin
Drug class: Direct thrombin inhibitors
Group: Anticoagulants and antiplatelets
Route: Intravenous
Dosage form: Injectable
Applicant: Eugia Pharma
Status: Discontinued
FDA approval: 27 Jul 2018
Application: ANDA205962-001
RxCUI: 60819

Guidelines

FDA 2025

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