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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204326
Company: NEOS THERAPS

Medication Guide

Products on NDA 204326

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADZENYS XR-ODT	AMPHETAMINE	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ADZENYS XR-ODT	AMPHETAMINE	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ADZENYS XR-ODT	AMPHETAMINE	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ADZENYS XR-ODT	AMPHETAMINE	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ADZENYS XR-ODT	AMPHETAMINE	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
ADZENYS XR-ODT	AMPHETAMINE	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204326

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204326Orig1_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204326s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204325Orig1s003; 204326Orig1s008ltr.pdf
01/04/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204326Orig1s002ltr.pdf
11/18/2016	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s001ltr.pdf

Labels for NDA 204326

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204326s008lbl.pdf
01/04/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf
11/18/2016	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf
01/27/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf

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