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Elspar

asparaginase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Elspar

Proper name

asparaginase

Licence type

351(a)

BLA number

101063

Applicant

Recordati Rare Diseases, Inc.

Center

CDER

Presentations

1

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
10,000INTERNATIONAL UNITS	For Injection	Intravenous, Intramuscular	Single-Dose Vial	Disc	January 10, 1978

Sources for this page

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