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Orencia

abatacept

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Orencia

Proper name

abatacept

Licence type

351(a)

BLA number

125118

Applicant

Bristol-Myers Squibb Company

Center

CDER

Presentations

5

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
125MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	July 29, 2011
125MG/ML	Injection	Subcutaneous	Autoinjector	Rx	June 7, 2016
250MG	For Injection	Intravenous	Single-Dose Vial	Rx	December 23, 2005
50MG/0.4ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	March 30, 2017
87.5MG/0.7ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	March 30, 2017

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	December 15, 2028

Sources for this page

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