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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021879

NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE)
20MG;10MG
Marketing Status: Prescription
Active Ingredient: DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Proprietary Name: NUEDEXTA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG;10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021879
Product Number: 001
Approval Date: Oct 29, 2010
Applicant Holder Full Name: AVANIR PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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