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Asparlas

calaspargase pegol-mknl

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Asparlas

Proper name

calaspargase pegol-mknl

Licence type

351(a)

BLA number

761102

Applicant

Servier Pharmaceuticals LLC

Center

CDER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
3,750UNITS/5ML (750UNITS/ML)	Injection	Intravenous	Single-Dose Vial	Rx	December 20, 2018

Source: Purple Book

Kind	Expires
Orphan exclusivity	February 1, 2001

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