Product Details for: Gonal-f RFF Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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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 | Rx |
003 | For Injection | Subcutaneous | 150IU | Single-Dose Vial | 351(a) | Gonal-f RFF | Disc |
Proper Name
follitropin alfa
BLA Number
021765
Applicant
EMD Serono, Inc.
Original Approval Date
March 25, 2004
Date of First Licensure