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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208147
Company: TRIS PHARMA INC

Medication Guide

Summary Review

Products on NDA 208147

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DYANAVEL XR	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	2MG/ML;EQ 0.5MG BASE/ML	SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208147

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/19/2015	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208147s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208147Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208147Orig1DyanavelTOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208147Orig1s000SumR_6pgs_rev1rev2kc_Redacted.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208147s016,210526s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208147Orig1s016; 210526Orig1s008ltr.pdf
02/25/2022	SUPPL-13	Labeling-Package Insert	Label Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208147Orig1s013; 210526Orig1s003correctedltr.pdf
06/01/2022	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s012,210526Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208147Orig1s012; 210526Orig1s001ltr.pdf
02/05/2019	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208147s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208147Orig1s005ltr.pdf
05/12/2017	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208147s003lbl.pdf
01/04/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208147s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208147Orig1s002ltr.pdf

Labels for NDA 208147

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208147s016,210526s008lbl.pdf
10/13/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208147s016,210526s008lbl.pdf
06/01/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s012,210526Orig1s001lbl.pdf
02/25/2022	SUPPL-13	Labeling-Package Insert			https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt
02/05/2019	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208147s005lbl.pdf
05/12/2017	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208147s003lbl.pdf
01/04/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208147s002lbl.pdf
10/19/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208147s000lbl.pdf

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