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FDA Drug Approval, N212613, GANIRELIX ACETATE
FDA Drug Approval, N212613, GANIRELIX ACETATE
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NDA: 212613
Company: AMPHASTAR PHARMS INC
Drug Name: GANIRELIX ACETATE
Active Ingredients: GANIRELIX ACETATE
Strength: 250MCG/0.5ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 04/07/2022
Marketing Status: Prescription
Submission Classification:
Company: AMPHASTAR PHARMS INC
Drug Name: GANIRELIX ACETATE
Active Ingredients: GANIRELIX ACETATE
Strength: 250MCG/0.5ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 04/07/2022
Marketing Status: Prescription
Submission Classification:
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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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