Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208147

EQ 2.5MG BASE/ML Marketing Status: Prescription

Active Ingredient: AMPHETAMINE
Proprietary Name: DYANAVEL XR
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; ORAL
Strength: EQ 2.5MG 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
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