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FDA NDA · NDA208147

DYANAVEL XR

amphetamine

Sponsor: TRIS PHARMA INC

APPLICATION
NDA208147
TYPE
NDA
ORIGINAL APPROVAL
2015-10-19
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DYANAVEL XR · ReferencePrescription
AMPHETAMINE 2MG/ML, AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE EQ 0.5MG BASE/ML · SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 18 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 16 · standard — Letter ↗AP
2022-06-01Labeling · Supplement 12 · standard — Letter ↗AP
2022-02-25Labeling · Supplement 13 · 901 required — Letter ↗AP
2019-02-05Efficacy · Supplement 5 · standard — Label ↗AP
2017-05-12Manufacturing (CMC) · Supplement 3 — Label ↗AP
2017-01-04Labeling · Supplement 2 · 901 required — Label ↗AP
2015-10-19Type 3 - New Dosage Form · Original · standard — Pediatric Medical Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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