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FDA Drug Approval, N211964, QELBREE
FDA Drug Approval, N211964, QELBREE
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NDA: 211964
Company: SUPERNUS PHARMS
Drug Name: QELBREE
Active Ingredients: VILOXAZINE HYDROCHLORIDE
Strength: EQ 200MG BASE
Dosage Form/Route: CAPSULE, EXTENDED RELEASE;ORAL
Action Date: 04/02/2021
Marketing Status: Prescription
Submission Classification: Type 1 - New Molecular Entity
Company: SUPERNUS PHARMS
Drug Name: QELBREE
Active Ingredients: VILOXAZINE HYDROCHLORIDE
Strength: EQ 200MG BASE
Dosage Form/Route: CAPSULE, EXTENDED RELEASE;ORAL
Action Date: 04/02/2021
Marketing Status: Prescription
Submission Classification: Type 1 - New Molecular Entity
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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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