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Purple Book
Database of Licensed Biological Products

Product Details for: Gonal-f
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 InjectionSubcutaneous75IUAmpule351(a)Gonal-fDisc
002For InjectionSubcutaneous150IUAmpule351(a)Gonal-fDisc
003For InjectionSubcutaneous37.5IUAmpule351(a)Gonal-fDisc
004For InjectionSubcutaneous1,050IU (600IU/ML)Multi-Dose Vial351(a)Gonal-fRx
005For InjectionSubcutaneous450IU (600IU/ML)Multi-Dose Vial351(a)Gonal-fRx

Proper Name
follitropin alfa

BLA Number
020378

Applicant
EMD Serono, Inc.

Original Approval Date
September 29, 1997

Date of First Licensure