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Leukine

sargramostim

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Leukine

Proper name

sargramostim

Licence type

351(a)

BLA number

103362

Applicant

Partner Therapeutics, Inc.

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
250MCG	For Injection	Intravenous, Subcutaneous	Single-Dose Vial	Rx	March 5, 1991
500MCG/ML	Injection	Intravenous, Subcutaneous	Multi-Dose Vial	Disc	March 5, 1991

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 29, 2025

Sources for this page

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