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Kepivance

palifermin

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Kepivance

Proper name

palifermin

Licence type

351(a)

BLA number

125103

Applicant

Swedish Orphan Biovitrum AB (publ)

Center

CDER

Presentations

1

First licensure

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Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
6.25MG	For Injection	Intravenous	Single-Dose Vial	Rx	December 15, 2004

Sources for this page

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