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Octaplas

Pooled Plasma (Human), Solvent/Detergent Treated

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Octaplas

Proper name

Pooled Plasma (Human), Solvent/Detergent Treated

Licence type

351(a)

BLA number

125416

Applicant

Octapharma Pharmazeutika Produktionsges.m.b.H.

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
45-70MG/ML	For Injection	Intravenous	Bag	Rx	January 17, 2013

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