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Follistim

follitropin beta

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Follistim

Proper name

follitropin beta

Licence type

351(a)

BLA number

020582

Applicant

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

Center

CDER

Presentations

2

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
150IU	For Injection	Subcutaneous, Intramuscular	Single-Dose Vial	Disc	September 29, 1997
75IU	For Injection	Subcutaneous, Intramuscular	Single-Dose Vial	Disc	September 29, 1997

Sources for this page

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