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Nabi-HB

Hepatitis B Immune Globulin (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Nabi-HB

Proper name

Hepatitis B Immune Globulin (Human)

Licence type

351(a)

BLA number

103945

Applicant

ADMA Biologics, Inc.

Center

CBER

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
1560IU/5ML	Injection	Intramuscular	Single-Dose Vial	Rx	October 23, 2001
312IU/ML	Injection	Intramuscular	Single-Dose Vial	Disc	October 23, 2001

Sources for this page

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