← FDA DRUG APPROVALS

FDA NDA · NDA204326

AMPHETAMINE EXTENDED-RELEASE

Sponsor: NEOS THERAPS

APPLICATION
NDA204326
TYPE
NDA
ORIGINAL APPROVAL
2016-01-27
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ADZENYS XR-ODT · ReferencePrescription
AMPHETAMINE EQ 18.8MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
ADZENYS XR-ODT · ReferencePrescription
AMPHETAMINE EQ 12.5MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
ADZENYS XR-ODT · ReferencePrescription
AMPHETAMINE EQ 6.3MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
ADZENYS XR-ODT · ReferencePrescription
AMPHETAMINE EQ 15.7MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
ADZENYS XR-ODT · ReferencePrescription
AMPHETAMINE EQ 9.4MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
ADZENYS XR-ODT · ReferencePrescription
AMPHETAMINE EQ 3.1MG BASE · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 20 · standard — Letter ↗AP
2025-04-01Labeling · Supplement 18 · standard — Label ↗AP
2025-03-28Manufacturing (CMC) · Supplement 12 — Letter ↗AP
2024-03-12Manufacturing (CMC) · Supplement 14 — Letter ↗AP
2023-10-13Labeling · Supplement 11 · standard — Letter ↗AP
2022-02-25Labeling · Supplement 8 · 901 required — Letter ↗AP
2017-01-04Labeling · Supplement 2 · 901 required — Label ↗AP
2016-11-18Labeling · Supplement 1 · standard — Letter ↗AP
2016-01-27Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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