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gammar i.v.,gammar-p i.v.

Immune Globulin Intravenous (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

gammar i.v.,gammar-p i.v.

Proper name

Immune Globulin Intravenous (Human)

Licence type

351(a)

BLA number

103956

Applicant

CSL Behring LLC

Center

CBER

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
10G	For Injection	Intravenous	Vial	Disc	March 17, 2000
1G	For Injection	Intravenous	Vial	Disc	March 17, 2000
2.5G	For Injection	Intravenous	Vial	Disc	March 17, 2000
5G	For Injection	Intravenous	Vial	Disc	March 17, 2000

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