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Simulect

basiliximab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Simulect

Proper name

basiliximab

Licence type

351(a)

BLA number

103764

Applicant

Novartis Pharmaceuticals Corporation

Center

CDER

Presentations

2

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
10MG	For Injection	Intravenous	Single-Dose Vial	Rx	January 2, 2003
20MG	For Injection	Intravenous	Single-Dose Vial	Rx	May 12, 1998

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	May 12, 2005

Sources for this page

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