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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208147

DYANAVEL XR (AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE)
2MG/ML;EQ 0.5MG BASE/ML
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Proprietary Name: DYANAVEL XR
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; ORAL
Strength: 2MG/ML;EQ 0.5MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208147
Product Number: 001
Approval Date: Oct 19, 2015
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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