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FDA NDA · NDA021977

VYVANSE

lisdexamfetamine dimesylate

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA021977
TYPE
NDA
ORIGINAL APPROVAL
2007-02-23
LATEST ACTION
2026-04-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 60MG · CAPSULE · ORAL
VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 20MG · CAPSULE · ORAL
VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 50MG · CAPSULE · ORAL
VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 10MG · CAPSULE · ORAL
VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 40MG · CAPSULE · ORAL
VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 70MG · CAPSULE · ORAL
VYVANSE · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 30MG · CAPSULE · ORAL

Approval history

2026-04-23Labeling · Supplement 52 · standardLabelAP
2025-09-23Labeling · Supplement 54 · standardLetterAP
2023-10-13Labeling · Supplement 50 · standardLabelAP
2022-02-25Labeling · Supplement 48 · 901 requiredLetterAP
2021-11-02Labeling · Supplement 47 · standardLetterAP
2021-07-29Efficacy · Supplement 46 · priorityLabelAP
2017-07-31Labeling · Supplement 34 · standardLabelAP
2017-05-19Labeling · Supplement 45 · 901 requiredLabelAP
2017-01-28Labeling · Supplement 44 · standardLetterAP
2017-01-06Labeling · Supplement 43 · 901 requiredLabelAP
2016-10-14Efficacy · Supplement 41 · standardLetterAP
2016-10-14Labeling · Supplement 42 · standardLetterAP
2016-04-15Manufacturing (CMC) · Supplement 20 · standardAP
2015-12-04Manufacturing (CMC) · Supplement 40 · standardAP
2015-04-17Labeling · Supplement 39 · standardLabelAP
2015-01-30Efficacy · Supplement 37 · priorityLabelAP
2015-01-30Labeling · Supplement 36 · standardLetterAP
2014-11-14Labeling · Supplement 33 · standardLabelAP
2014-10-30Manufacturing (CMC) · Supplement 35 · standardAP
2014-07-18Labeling · Supplement 31 · standardLabelAP
2014-07-18Labeling · Supplement 32 · standardLabelAP
2014-05-14Manufacturing (CMC) · Supplement 29 · standardAP
2013-12-06Labeling · Supplement 30 · standardLabelAP
2013-06-14Labeling · Supplement 28 · standardLabelAP
2013-04-26Efficacy · Supplement 27 · standardPediatric Medical ReviewAP
2012-11-19Labeling · Supplement 25 · standardLetterAP
2012-11-19Labeling · Supplement 26 · standardLetterAP
2012-11-19Labeling · Supplement 24 · standardLabelAP
2012-01-31Efficacy · Supplement 22 · standardLabelAP
2011-09-01Labeling · Supplement 23 · standardLetterAP
2011-03-16Labeling · Supplement 12 · unknownLabelAP
2010-11-10Labeling · Supplement 19 · unknownLetterAP
2010-11-10Labeling · Supplement 21 · standardLabelAP
2010-11-10Labeling · Supplement 18 · unknownLabelAP
2010-11-10Efficacy · Supplement 16 · standardLetterAP
2010-04-05Efficacy · Supplement 10 · standardLabelAP
2010-04-05Labeling · Supplement 15 · unknownLabelAP
2009-12-02Labeling · Supplement 13 · standardLabelAP
2009-05-22Labeling · Supplement 6 · standardLetterAP
2009-05-22Efficacy · Supplement 7 · unknownLabelAP
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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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