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Cytogam

Cytomegalovirus Immune Globulin Intravenous (Human)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Cytogam

Proper name

Cytomegalovirus Immune Globulin Intravenous (Human)

Licence type

351(a)

BLA number

103189

Applicant

Kamada Ltd.

Center

CBER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
2.5G/50ML	Injection	Intravenous	Single-Dose Vial	Rx	April 17, 1990

Source: Purple Book

Kind	Expires
Orphan exclusivity	October 4, 2005

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