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Medicines · US (FDA)

FDA 2016

FDA

Bivalirudin

Approved 14 Sept 2016IntravenousInjectable

The FDA lists this product in 13 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: BIVALIRUDIN 250MG/VIAL

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

BIVALIRUDIN 250MG/VIAL · InjectableANDA205962-001 · Discontinued
BIVALIRUDIN 250MG/VIAL · InjectableANDA206551-001 · Prescription
BIVALIRUDIN 250MG/VIAL · InjectableANDA213078-001 · Prescription
BIVALIRUDIN 250MG/VIAL · InjectableANDA091468-001 · Tentative approval
BIVALIRUDIN 250MG/VIAL · InjectableANDA091602-001 · Prescription
BIVALIRUDIN 250MG/VIAL · InjectableANDA210031-001 · Prescription
BIVALIRUDIN 250MG/VIAL · InjectableANDA090816-001 · Discontinued
BIVALIRUDIN 250MG/VIAL · InjectableThis page
BIVALIRUDIN 250MG/VIAL · InjectableANDA202471-001 · Prescription
BIVALIRUDIN 250MG/VIAL · InjectableANDA090189-001 · Prescription
BIVALIRUDIN 250MG/VIAL · InjectableANDA201577-001 · Prescription
BIVALIRUDIN 250MG/VIAL · InjectableANDA204876-001 · Discontinued
BIVALIRUDIN 250MG/VIAL · Injectable

At a glance

Brand name: Bivalirudin
Route: Intravenous
Dosage form: Injectable
Applicant: Pliva Hrvatska Doo
Status: Tentative approval
FDA approval: 14 Sept 2016
Application: ANDA091206-001

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA090811-001 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA091206.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.