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FDA Drug Approval, N021879, NUEDEXTA
FDA Drug Approval, N021879, NUEDEXTA
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NDA: 021879
Company: AVANIR PHARMS
Drug Name: NUEDEXTA
Active Ingredients: DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Strength: 20MG;10MG
Dosage Form/Route: CAPSULE;ORAL
Action Date: 10/29/2010
Marketing Status: Prescription
Submission Classification: Type 4 - New Combination
Company: AVANIR PHARMS
Drug Name: NUEDEXTA
Active Ingredients: DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Strength: 20MG;10MG
Dosage Form/Route: CAPSULE;ORAL
Action Date: 10/29/2010
Marketing Status: Prescription
Submission Classification: Type 4 - New Combination
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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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