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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209905
Company: AZURITY

Medication Guide

Products on NDA 209905

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EVEKEO ODT	AMPHETAMINE SULFATE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
EVEKEO ODT	AMPHETAMINE SULFATE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
EVEKEO ODT	AMPHETAMINE SULFATE	15MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
EVEKEO ODT	AMPHETAMINE SULFATE	20MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
EVEKEO ODT	AMPHETAMINE SULFATE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209905

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/2019	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209905s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209905Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209905Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209905s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209905Orig1s004ltr.pdf
09/30/2022	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209905s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209905Orig1s003ltr.pdf
02/25/2022	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209905s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209905Orig1s002_Corrected_ltr.pdf
04/16/2021	SUPPL-1	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209905Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209905Orig1s001ltr.pdf

Labels for NDA 209905

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209905s004lbl.pdf
10/13/2023	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209905s004lbl.pdf
09/30/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209905s003lbl.pdf
02/25/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209905s002lbl.pdf
04/16/2021	SUPPL-1	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209905Orig1s001lbl.pdf
01/30/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209905s000lbl.pdf

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