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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022063
Company: TAKEDA PHARMS USA

Medication Guide

Products on NDA 022063

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022063

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022063Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/022063Orig1s000TOC.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, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022063s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021303Orig1s036; 021977Orig1s048; 022063Orig1s003; 208510Orig1s005ltr.pdf
09/13/2019	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022063s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022063Orig1s001ltr.pdf

Labels for NDA 022063

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/2022/022063s003lbl.pdf
02/25/2022	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022063s003lbl.pdf
09/13/2019	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022063s001lbl.pdf
06/20/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf

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