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Follistim AQ

follitropin beta

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Follistim AQ

Proper name

follitropin beta

Licence type

351(a)

BLA number

021273

Applicant

Organon USA Inc., a subsidiary of Merck & Co., Inc.

Center

CDER

Presentations

2

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
150IU/0.5ML	Injection	Subcutaneous, Intramuscular	Single-Dose Vial	Disc	August 26, 2005
75IU/0.5ML	Injection	Subcutaneous, Intramuscular	Single-Dose Vial	Disc	August 26, 2005

Sources for this page

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