← FDA Drug Approvals (Drugs@FDA)

BIVALIRUDIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MEITHEAL · Approved 2018-07-16

Drug application

FDA Application #

ANDA091602

Application type

Abbreviated New Drug Application (Generic)

Brand name

BIVALIRUDIN

Generic name

BIVALIRUDIN

Active ingredients

BIVALIRUDIN

Dosage form

INJECTABLE

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

MEITHEAL

Manufacturer

Meitheal Pharmaceuticals Inc.

First approval

2018-07-16

Source

Authoritative

Drugs@FDA application overview

Machine

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