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Oncaspar

pegaspargase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Oncaspar

Proper name

pegaspargase

Licence type

351(a)

BLA number

103411

Applicant

Servier Pharmaceuticals LLC

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
3,750IU/5ML(750IU/ML)	Injection	Intravenous, Intramuscular	Single-Dose Vial	Rx	February 1, 1994

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	February 1, 2001

Sources for this page

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