Product Details for: Gonal-f RFF
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
37.5IU
Single-Dose Vial
351(a)
Gonal-f RFF
Disc
002
For Injection
Subcutaneous
75IU
Single-Dose Vial
351(a)
Gonal-f RFF
Disc
003
For Injection
Subcutaneous
150IU
Single-Dose Vial
351(a)
Gonal-f RFF
Disc
Proper Name
follitropin alfa
follitropin alfa
BLA Number
021765
021765
Applicant
EMD Serono, Inc.
EMD Serono, Inc.
Original Approval Date
March 25, 2004
March 25, 2004
Date of First Licensure