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Follistim AQ Cartridge

follitropin beta

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Follistim AQ Cartridge

Proper name

follitropin beta

Licence type

351(a)

BLA number

021211

Applicant

Organon USA LLC, a subsidiary of Organon & Co.

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
175IU/0.21ML	Injection	Subcutaneous	Multi-Dose Cartridge	Disc	February 11, 2005
300IU/0.36ML	Injection	Subcutaneous	Multi-Dose Cartridge	Rx	March 23, 2004
600IU/0.72ML	Injection	Subcutaneous	Multi-Dose Cartridge	Rx	March 23, 2004
900IU/1.08ML	Injection	Subcutaneous	Multi-Dose Cartridge	Rx	February 11, 2005

Sources for this page

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