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FDA Drug/Biologics Approval BLA 020378, FOLLITROPIN ALFA/BETA
FDA Drug/Biologics Approval BLA 020378, FOLLITROPIN ALFA/BETA
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BLA 020378
Company: EMD SERONO
Drug Name: GONAL-F
Active Ingredients: FOLLITROPIN ALFA/BETA
Strength: 450 IU/VIAL
Dosage Form/Route: INJECTABLE;SUBCUTANEOUS
Action Date: 09/29/1997
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: EMD SERONO
Drug Name: GONAL-F
Active Ingredients: FOLLITROPIN ALFA/BETA
Strength: 450 IU/VIAL
Dosage Form/Route: INJECTABLE;SUBCUTANEOUS
Action Date: 09/29/1997
Marketing Status: Prescription
Submission Classification: ORIG-1
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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