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FDA Drug Approval, N211939, BONSITY
FDA Drug Approval, N211939, BONSITY
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NDA: 211939
Company: ALVOGEN
Drug Name: BONSITY
Active Ingredients: TERIPARATIDE
Strength: 0.62MG/2.48ML (0.25MG/ML)
Dosage Form/Route: SOLUTION;SUBCUTANEOUS
Action Date: 10/04/2019
Marketing Status: Prescription
Submission Classification: Type 5 - New Formulation or New Manufacturer
Company: ALVOGEN
Drug Name: BONSITY
Active Ingredients: TERIPARATIDE
Strength: 0.62MG/2.48ML (0.25MG/ML)
Dosage Form/Route: SOLUTION;SUBCUTANEOUS
Action Date: 10/04/2019
Marketing Status: Prescription
Submission Classification: Type 5 - New Formulation or New Manufacturer
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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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