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FDA NDA · NDA219847

ARYNTA

lisdexamfetamine dimesylate oral

Sponsor: AZURITY

APPLICATION
NDA219847
TYPE
NDA
ORIGINAL APPROVAL
2025-06-16
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ARYNTA · ReferencePrescription
LISDEXAMFETAMINE DIMESYLATE 10MG/ML · SOLUTION · ORAL

Approval history

2025-12-22Labeling · Supplement 1 · standardLabelAP
2025-06-16Type 3 - New Dosage Form · Original · standardLabelAP
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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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