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Gonal-f RFF

follitropin alfa

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Gonal-f RFF

Proper name

follitropin alfa

Licence type

351(a)

BLA number

021765

Applicant

EMD Serono, Inc.

Center

CDER

Presentations

3

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	Single-Dose Vial	Disc	March 25, 2004
37.5IU	For Injection	Subcutaneous	Single-Dose Vial	Disc	March 25, 2004
75IU	For Injection	Subcutaneous	Single-Dose Vial	Disc	March 25, 2004

Sources for this page

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