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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210526
Company: TRIS PHARMA INC

Medication Guide

Products on NDA 210526

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DYANAVEL XR 10	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
DYANAVEL XR 15	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
DYANAVEL XR 20	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes
DYANAVEL XR 5	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210526

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/04/2021	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210526s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210526Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/210526Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208147s018,210526s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208147Orig1s018;210526Orig1s010ltr.pdf
10/13/2023	SUPPL-8	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-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147s013,210526s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208147Orig1s013; 210526Orig1s003correctedltr.pdf
10/14/2022	SUPPL-2	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210526Orig1s002ltr.pdf
06/01/2022	SUPPL-1	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

Labels for NDA 210526

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208147s018,210526s010lbl.pdf
09/23/2025	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208147s018,210526s010lbl.pdf
10/13/2023	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208147s016,210526s008lbl.pdf
10/13/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208147s016,210526s008lbl.pdf
06/01/2022	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s012,210526Orig1s001lbl.pdf
02/25/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147s013,210526s003lbl.pdf
11/04/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210526s000lbl.pdf

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