Application 204326

Type: NDA
Sponsor: NEOS THERAPS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADZENYS XR-ODT	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 3.1MG BASE	Yes	No
002	ADZENYS XR-ODT	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 6.3MG BASE	Yes	No
003	ADZENYS XR-ODT	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 9.4MG BASE	Yes	No
004	ADZENYS XR-ODT	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 12.5MG BASE	Yes	No
005	ADZENYS XR-ODT	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 15.7MG BASE	Yes	No
006	ADZENYS XR-ODT	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 18.8MG BASE	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204326-001	ADZENYS XR-ODT	AMPHETAMINE	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27
N204326-002	ADZENYS XR-ODT	AMPHETAMINE	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27
N204326-003	ADZENYS XR-ODT	AMPHETAMINE	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27
N204326-004	ADZENYS XR-ODT	AMPHETAMINE	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27
N204326-005	ADZENYS XR-ODT	AMPHETAMINE	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27
N204326-006	ADZENYS XR-ODT	AMPHETAMINE	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2016-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N204326-001	AB
N204326-002	AB
N204326-003	AB
N204326-004	AB
N204326-005	AB
N204326-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N204326-001	8840924	2026-04-09	Drug product	2016-02-26
N204326-001	8709491	2032-06-28	Drug product	2016-02-26
N204326-001	9017731	2032-06-28	Drug product	2016-02-26
N204326-001	9265737	2032-06-28	Drug product	2016-02-26
N204326-001	9839619	2032-06-28	Drug product	2024-04-22
N204326-002	8840924	2026-04-09	Drug product	2016-02-26
N204326-002	8709491	2032-06-28	Drug product
N204326-002	9017731	2032-06-28	Drug product
N204326-002	9265737	2032-06-28	Drug product
N204326-002	9839619	2032-06-28	Drug product	2024-04-22
N204326-003	8840924	2026-04-09	Drug product	2016-02-26
N204326-003	8709491	2032-06-28	Drug product
N204326-003	9017731	2032-06-28	Drug product
N204326-003	9265737	2032-06-28	Drug product
N204326-003	9839619	2032-06-28	Drug product	2024-04-22
N204326-004	8840924	2026-04-09	Drug product	2016-02-26
N204326-004	8709491	2032-06-28	Drug product
N204326-004	9017731	2032-06-28	Drug product
N204326-004	9265737	2032-06-28	Drug product
N204326-004	9839619	2032-06-28	Drug product	2024-04-22
N204326-005	8840924	2026-04-09	Drug product	2016-02-26
N204326-005	8709491	2032-06-28	Drug product
N204326-005	9017731	2032-06-28	Drug product
N204326-005	9265737	2032-06-28	Drug product
N204326-005	9839619	2032-06-28	Drug product	2024-04-22
N204326-006	8840924	2026-04-09	Drug product	2016-02-26
N204326-006	8709491	2032-06-28	Drug product
N204326-006	9017731	2032-06-28	Drug product
N204326-006	9265737	2032-06-28	Drug product
N204326-006	9839619	2032-06-28	Drug product	2024-04-22

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N204326-001	ADZENYS XR-ODT	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	ADZENYS XR-ODT	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	ADZENYS XR-ODT	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	ADZENYS XR-ODT	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	ADZENYS XR-ODT	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	ADZENYS XR-ODT	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2016-01-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N204326-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N204326-001	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-001	8709491	2032-06-28	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-001	9017731	2032-06-28	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-001	9265737	2032-06-28	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-001	9839619	2032-06-28	Drug product	2024-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	8709491	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	9017731	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	9265737	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	9839619	2032-06-28	Drug product	2024-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	8709491	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	9017731	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	9265737	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	9839619	2032-06-28	Drug product	2024-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	8709491	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	9017731	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	9265737	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	9839619	2032-06-28	Drug product	2024-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	8709491	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	9017731	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	9265737	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	9839619	2032-06-28	Drug product	2024-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	8709491	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	9017731	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	9265737	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	9839619	2032-06-28	Drug product	2024-04-22	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adzenys XR-ODT	AMPHETAMINE	Neos Therapeutics Brands, LLC	c1179269-00b5-48ea-972d-31e614e99b7e	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204326 application number: NDA204326 ndc (product): 70165-005 ndc (product): 70165-015 ndc (product): 70165-020 ndc (product): 70165-030 ndc (product): 70165-025 ndc (product): 70165-010
Amphetamine Extended-Release	AMPHETAMINE EXTENDED-RELEASE	Neos Therapeutics, LP	48d0f55c-f847-4d26-b2ed-94b5a2770228	2025-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204326 application number: NDA204326

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70165-005	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current
70165-005	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-005	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-005	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current
70165-010	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current
70165-010	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-010	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-010	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current
70165-015	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current
70165-015	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-015	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-015	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current
70165-020	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current
70165-020	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-020	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-020	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current
70165-025	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current
70165-025	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-025	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-025	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current
70165-030	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current
70165-030	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-030	Adzenys XR-ODT	Amphetamine	Neos Therapeutics, LP	NDA	Current
70165-030	Adzenys XR-ODT	Amphetamine	Neos Therapeutics Brands, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81808	SUPPL	2025-12-12
83487	SUPPL	2025-09-25
83486	SUPPL	2025-09-25
83448	SUPPL	2025-09-25
83002	SUPPL	2025-07-31
82995	SUPPL	2025-07-31
81872	SUPPL	2025-04-08
78093	SUPPL	2024-04-09
78092	SUPPL	2024-04-09
75781	SUPPL	2023-10-17
75772	SUPPL	2023-10-16
70388	SUPPL	2022-03-03
70386	SUPPL	2022-03-03
70298	SUPPL	2022-02-28
67753	SUPPL	2021-06-09
46727	SUPPL	2017-01-09
46685	SUPPL	2017-01-06
46434	ORIG	2016-12-21
45987	SUPPL	2016-12-01
45923	SUPPL	2016-11-22
45922	ORIG	2016-01-28
45921	ORIG	2016-01-28
51526	ORIG	1900-01-01
51525	ORIG	1900-01-01