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Synagis

palivizumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Synagis

Proper name

palivizumab

Licence type

351(a)

BLA number

103770

Applicant

Swedish Orphan Biovitrum AB (publ)

Center

CDER

Presentations

4

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
100MG	For Injection	Intramuscular	Single-Dose Vial	Disc	June 19, 1998
100MG/1ML	Injection	Intramuscular	Single-Dose Vial	Rx	July 23, 2004
50MG	For Injection	Intramuscular	Single-Dose Vial	Disc	June 19, 1998
50MG/0.5ML	Injection	Intramuscular	Single-Dose Vial	Rx	July 23, 2004

Sources for this page

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