Product Details for: Gonal-f

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
75IU
Ampule
351(a)
Gonal-f
Disc
002
For Injection
Subcutaneous
150IU
Ampule
351(a)
Gonal-f
Disc
003
For Injection
Subcutaneous
37.5IU
Ampule
351(a)
Gonal-f
Disc
004
For Injection
Subcutaneous
1,050IU (600IU/ML)
Multi-Dose Vial
351(a)
Gonal-f
Rx
005
For Injection
Subcutaneous
450IU (600IU/ML)
Multi-Dose Vial
351(a)
Gonal-f
Rx
Proper Name
follitropin alfa
BLA Number
020378
Applicant
EMD Serono, Inc.
Original Approval Date
September 29, 1997
Date of First Licensure
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