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Purple Book
Database of Licensed Biological Products

Product Details for: Gonal-f RFF
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001For InjectionSubcutaneous37.5IUSingle-Dose Vial351(a)Gonal-f RFFDisc
002For InjectionSubcutaneous75IUSingle-Dose Vial351(a)Gonal-f RFFRx
003For InjectionSubcutaneous150IUSingle-Dose Vial351(a)Gonal-f RFFDisc

Proper Name
follitropin alfa

BLA Number
021765

Applicant
EMD Serono, Inc.

Original Approval Date
March 25, 2004

Date of First Licensure