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Spherusol

Coccidioides immitis Spherule-Derived Skin Test Antigen

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Spherusol

Proper name

Coccidioides immitis Spherule-Derived Skin Test Antigen

Licence type

351(a)

BLA number

125354

Applicant

Nielsen Bioscience, Inc

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
1.0ML	Injection	Intradermal	Multi-Dose Vial	Rx	July 29, 2011

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