Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204325
Company: NEOS THERAPS INC

• Medication Guide

Products on NDA 204325

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADZENYS ER	AMPHETAMINE	EQ 1.25MG BASE/ML	SUSPENSION, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204325

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204325s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204325Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204325Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2022	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204325s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204325Orig1s003; 204326Orig1s008ltr.pdf

Labels for NDA 204325

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204325s003lbl.pdf
09/15/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204325s000lbl.pdf