Application 215401

Type: NDA
Sponsor: NOVEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XELSTRYM	DEXTROAMPHETAMINE	SYSTEM; TRANSDERMAL	4.5MG/9HR	No	No
002	XELSTRYM	DEXTROAMPHETAMINE	SYSTEM; TRANSDERMAL	9MG/9HR	No	No
003	XELSTRYM	DEXTROAMPHETAMINE	SYSTEM;TRANSDERMAL	13.5MG/9HR	No	No
004	XELSTRYM	DEXTROAMPHETAMINE	SYSTEM;TRANSDERMAL	18.5MG/9HR	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215401-001	XELSTRYM	DEXTROAMPHETAMINE	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22
N215401-002	XELSTRYM	DEXTROAMPHETAMINE	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22
N215401-003	XELSTRYM	DEXTROAMPHETAMINE	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22
N215401-004	XELSTRYM	DEXTROAMPHETAMINE	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215401-001	9456993	2033-10-24	U-3340	Drug product	2022-04-14
N215401-001	9474722	2033-10-24		Drug product	2022-04-14
N215401-001	11559501	2042-01-06		Drug product	2023-02-17
N215401-002	9456993	2033-10-24	U-3340	Drug product	2022-04-14
N215401-002	9474722	2033-10-24		Drug product	2022-04-14
N215401-002	11559501	2042-01-06		Drug product	2023-02-17
N215401-003	9456993	2033-10-24	U-3340	Drug product	2022-04-14
N215401-003	9474722	2033-10-24		Drug product	2022-04-14
N215401-003	11559501	2042-01-06		Drug product	2023-02-17
N215401-004	9456993	2033-10-24	U-3340	Drug product	2022-04-14
N215401-004	9474722	2033-10-24		Drug product	2022-04-14
N215401-004	11559501	2042-01-06		Drug product	2023-02-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N215401-001	XELSTRYM	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-002	XELSTRYM	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-003	XELSTRYM	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-004	XELSTRYM	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N215401-001	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-001	9474722	2033-10-24		Drug product	2022-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-001	11559501	2042-01-06		Drug product	2023-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-002	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-002	9474722	2033-10-24		Drug product	2022-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-002	11559501	2042-01-06		Drug product	2023-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-003	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-003	9474722	2033-10-24		Drug product	2022-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-003	11559501	2042-01-06		Drug product	2023-02-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-004	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-004	9474722	2033-10-24		Drug product	2022-04-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215401-004	11559501	2042-01-06		Drug product	2023-02-17	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XELSTRYM	DEXTROAMPHETAMINE	Noven Therapeutics, LLC	0862f02a-72a8-41cc-8845-57cf4974bb6f	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215401 application number: NDA215401 ndc (product): 68968-0215 ndc (product): 68968-0220 ndc (product): 68968-0210 ndc (product): 68968-0205

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68968-0205	XELSTRYM	DEXTROAMPHETAMINE	Noven Therapeutics, LLC	NDA	Current
68968-0210	XELSTRYM	DEXTROAMPHETAMINE	Noven Therapeutics, LLC	NDA	Current
68968-0215	XELSTRYM	DEXTROAMPHETAMINE	Noven Therapeutics, LLC	NDA	Current
68968-0220	XELSTRYM	DEXTROAMPHETAMINE	Noven Therapeutics, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83513	SUPPL	2025-09-25
83512	SUPPL	2025-09-25
83465	SUPPL	2025-09-25
80467	SUPPL	2024-12-02
80465	SUPPL	2024-12-02
75807	SUPPL	2023-10-17
71833	SUPPL	2022-08-17
71817	SUPPL	2022-08-17
70994	ORIG	2022-05-04
70602	ORIG	2022-03-25
70589	ORIG	2022-03-23