Product Details for: Gonal-f 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 | 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