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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215401
Company: NOVEN PHARMS INC

Medication Guide

Products on NDA 215401

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XELSTRYM	DEXTROAMPHETAMINE	4.5MG/9HR	SYSTEM;TRANSDERMAL	Prescription	None	Yes	No
XELSTRYM	DEXTROAMPHETAMINE	9MG/9HR	SYSTEM;TRANSDERMAL	Prescription	None	Yes	No
XELSTRYM	DEXTROAMPHETAMINE	13.5MG/9HR	SYSTEM;TRANSDERMAL	Prescription	None	Yes	No
XELSTRYM	DEXTROAMPHETAMINE	18MG/9HR	SYSTEM;TRANSDERMAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215401

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2022	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215401s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215401Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215401Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215401s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215401Orig1s015ltr.pdf
11/29/2024	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215401Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215401Orig1s011ltr.pdf
10/13/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215401s008lbl.pdf
08/16/2022	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215401s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215401Orig1s001ltr.pdf

Labels for NDA 215401

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215401s015lbl.pdf
11/29/2024	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215401Orig1s011lbl.pdf
10/13/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215401s008lbl.pdf
08/16/2022	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215401s001lbl.pdf
03/22/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215401s000lbl.pdf

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