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FDA NDA · NDA204325

ADZENYS ER

Sponsor: NEOS THERAPS INC

APPLICATION
NDA204325
TYPE
NDA
ORIGINAL APPROVAL
2017-09-15
LATEST ACTION
2022-02-25
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ADZENYS ER · ReferenceDiscontinued
AMPHETAMINE EQ 1.25MG BASE/ML · SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2022-02-25Labeling · Supplement 3 · 901 required — Letter ↗AP
2017-09-15Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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