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Reopro

abciximab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Reopro

Proper name

abciximab

Licence type

351(a)

BLA number

103575

Applicant

Janssen Biotech, Inc.

Center

CDER

Presentations

1

First licensure

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Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
2MG/ML	Injection	Intravenous	Single-Dose Vial	Disc	December 22, 1994

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity