Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210526

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DYANAVEL XR 10 (AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE)
8MG;EQ 2MG BASE
Marketing Status: Prescription

Active Ingredient: AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Proprietary Name: DYANAVEL XR 10
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 8MG;EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210526
Product Number: 002
Approval Date: Nov 4, 2021
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DYANAVEL XR 15 (AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE)
12MG;EQ 3MG BASE
Marketing Status: Prescription

Active Ingredient: AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Proprietary Name: DYANAVEL XR 15
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12MG;EQ 3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210526
Product Number: 003
Approval Date: Nov 4, 2021
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DYANAVEL XR 20 (AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE)
16MG;EQ 4MG BASE
Marketing Status: Prescription

Active Ingredient: AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Proprietary Name: DYANAVEL XR 20
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 16MG;EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210526
Product Number: 004
Approval Date: Nov 4, 2021
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DYANAVEL XR 5 (AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE)
4MG;EQ 1MG BASE
Marketing Status: Prescription

Active Ingredient: AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Proprietary Name: DYANAVEL XR 5
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 4MG;EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210526
Product Number: 001
Approval Date: Nov 4, 2021
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information