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FDA NDA · NDA208510

VYVANSE

lisdexamfetamine dimesylate

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA208510
TYPE
NDA
ORIGINAL APPROVAL
2017-01-28
LATEST ACTION
2026-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription

Products

VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 50MG · TABLET, CHEWABLE · ORAL
VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 30MG · TABLET, CHEWABLE · ORAL
VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 10MG · TABLET, CHEWABLE · ORAL
VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 60MG · TABLET, CHEWABLE · ORAL
VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 40MG · TABLET, CHEWABLE · ORAL
VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 20MG · TABLET, CHEWABLE · ORAL

Approval history

2026-04-23Labeling · Supplement 9 · standard — Label ↗AP
2025-09-23Labeling · Supplement 11 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 7 · standard — Label ↗AP
2022-02-25Labeling · Supplement 5 · 901 required — Letter ↗AP
2021-11-02Labeling · Supplement 4 · standard — Letter ↗AP
2021-07-29Efficacy · Supplement 3 · priority — Label ↗AP
2017-07-31Labeling · Supplement 2 · standard — Label ↗AP
2017-05-19Labeling · Supplement 1 · 901 required — Label ↗AP
2017-01-28Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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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