← FDA DRUG APPROVALS

FDA NDA · NDA215401

XELSTRYM

dextroamphetamine

Sponsor: NOVEN PHARMS INC

APPLICATION
NDA215401
TYPE
NDA
ORIGINAL APPROVAL
2022-03-22
LATEST ACTION
2026-07-10
ROUTE
TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

XELSTRYM · ReferencePrescription
DEXTROAMPHETAMINE 18MG/9HR · SYSTEM · TRANSDERMAL
XELSTRYM · ReferencePrescription
DEXTROAMPHETAMINE 9MG/9HR · SYSTEM · TRANSDERMAL
XELSTRYM · ReferencePrescription
DEXTROAMPHETAMINE 13.5MG/9HR · SYSTEM · TRANSDERMAL
XELSTRYM · ReferencePrescription
DEXTROAMPHETAMINE 4.5MG/9HR · SYSTEM · TRANSDERMAL

Approval history

2026-07-10Labeling · Supplement 16 · standard — Label ↗AP
2025-09-23Labeling · Supplement 15 · standard — Letter ↗AP
2024-11-29Labeling · Supplement 11 · standard — Label ↗AP
2023-10-13Labeling · Supplement 8 · standard — Label ↗AP
2022-08-16Labeling · Supplement 1 · standard — Letter ↗AP
2022-03-22Type 3 - New Dosage Form · Original · standard — Letter ↗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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