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Gonal-f

follitropin alfa

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Gonal-f
Proper name
follitropin alfa
Licence type
351(a)
BLA number
020378
Applicant
EMD Serono, Inc.
Center
CDER
Presentations
5
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
1,050IU (600IU/ML) For Injection Subcutaneous Multi-Dose Vial Rx February 28, 2001
150IU For Injection Subcutaneous Ampule Disc September 29, 1997
37.5IU For Injection Subcutaneous Ampule Disc March 25, 2004
450IU (600IU/ML) For Injection Subcutaneous Multi-Dose Vial Rx March 26, 2004
75IU For Injection Subcutaneous Ampule Disc September 29, 1997

Exclusivity

Source: Purple Book
Kind Expires
Orphan exclusivityMay 24, 2007

Sources for this page

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