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FDA NDA · NDA210526

DYANAVEL XR

amphetamine

Sponsor: TRIS PHARMA INC

APPLICATION
NDA210526
TYPE
NDA
ORIGINAL APPROVAL
2021-11-04
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DYANAVEL XR 20 · ReferencePrescription
AMPHETAMINE 16MG, AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE EQ 4MG BASE · TABLET, EXTENDED RELEASE · ORAL
DYANAVEL XR 10 · ReferencePrescription
AMPHETAMINE 8MG, AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE EQ 2MG BASE · TABLET, EXTENDED RELEASE · ORAL
DYANAVEL XR 15 · ReferencePrescription
AMPHETAMINE 12MG, AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE EQ 3MG BASE · TABLET, EXTENDED RELEASE · ORAL
DYANAVEL XR 5 · ReferencePrescription
AMPHETAMINE 4MG, AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE EQ 1MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 10 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 8 · standard — Letter ↗AP
2022-10-14Labeling · Supplement 2 · standard — Letter ↗AP
2022-06-01Labeling · Supplement 1 · standard — Letter ↗AP
2022-02-25Labeling · Supplement 3 · 901 required — Letter ↗AP
2021-11-04Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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