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Purple Book
Database of Licensed Biological Products

Product Details for: Gonal-f RFF RediJect
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
001Injection Subcutaneous300IU/0.5MLAutoinjector351(a)Gonal-f RFF RediJectRx
002Injection Subcutaneous450IU/0.75MLAutoinjector351(a)Gonal-f RFF RediJectRx
003Injection Subcutaneous900IU/1.5MLAutoinjector351(a)Gonal-f RFF RediJectRx

Proper Name
follitropin alfa

BLA Number
021684

Applicant
EMD Serono, Inc.

Original Approval Date
May 25, 2004

Date of First Licensure