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 42.

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.

Product history page 1 of 7 · 252 observed 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
2026-08-18 06:07:40	2026-07	N204326-001	ADZENYS XR-ODT	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-002	ADZENYS XR-ODT	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-003	ADZENYS XR-ODT	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-004	ADZENYS XR-ODT	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-005	ADZENYS XR-ODT	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-006	ADZENYS XR-ODT	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2016-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204326-001	ADZENYS XR-ODT	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-002	ADZENYS XR-ODT	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-003	ADZENYS XR-ODT	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-004	ADZENYS XR-ODT	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-005	ADZENYS XR-ODT	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-006	ADZENYS XR-ODT	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2016-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-001	ADZENYS XR-ODT	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-002	ADZENYS XR-ODT	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-003	ADZENYS XR-ODT	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-004	ADZENYS XR-ODT	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-005	ADZENYS XR-ODT	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-006	ADZENYS XR-ODT	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2016-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204326-001	ADZENYS XR-ODT	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204326-002	ADZENYS XR-ODT	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204326-003	ADZENYS XR-ODT	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204326-004	ADZENYS XR-ODT	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204326-005	ADZENYS XR-ODT	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204326-006	ADZENYS XR-ODT	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2016-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204326-001	ADZENYS XR-ODT	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204326-002	ADZENYS XR-ODT	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204326-003	ADZENYS XR-ODT	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204326-004	ADZENYS XR-ODT	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204326-005	ADZENYS XR-ODT	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204326-006	ADZENYS XR-ODT	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD, RS	2016-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204326-001	ADZENYS XR-ODT	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204326-002	ADZENYS XR-ODT	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204326-003	ADZENYS XR-ODT	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204326-004	ADZENYS XR-ODT	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204326-005	ADZENYS XR-ODT	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204326-006	ADZENYS XR-ODT	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD, RS	2016-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204326-001	ADZENYS XR-ODT	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204326-002	ADZENYS XR-ODT	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204326-003	ADZENYS XR-ODT	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204326-004	ADZENYS XR-ODT	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		RLD	2016-01-27	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N204326-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204326-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204326-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204326-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204326-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204326-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204326-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204326-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204326-006	AB	1	`6a471c1ec25d…`
2023-12-20 04:57 UTC	2023-12	N204326-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N204326-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N204326-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N204326-004	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N204326-005	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N204326-006	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204326-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204326-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204326-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204326-004	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204326-005	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204326-006	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204326-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204326-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204326-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204326-004	AB	1	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 28 · 1,104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204326-001	8840924	2026-04-09	Drug product	2016-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-001	8709491	2032-06-28	Drug product	2016-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-001	9017731	2032-06-28	Drug product	2016-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-001	9265737	2032-06-28	Drug product	2016-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-001	9839619	2032-06-28	Drug product	2024-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-002	8840924	2026-04-09	Drug product	2016-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-002	8709491	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-002	9017731	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-002	9265737	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-002	9839619	2032-06-28	Drug product	2024-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-003	8840924	2026-04-09	Drug product	2016-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-003	8709491	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-003	9017731	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-003	9265737	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-003	9839619	2032-06-28	Drug product	2024-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-004	8840924	2026-04-09	Drug product	2016-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-004	8709491	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-004	9017731	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-004	9265737	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-004	9839619	2032-06-28	Drug product	2024-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-005	8840924	2026-04-09	Drug product	2016-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-005	8709491	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-005	9017731	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-005	9265737	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-005	9839619	2032-06-28	Drug product	2024-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-006	8840924	2026-04-09	Drug product	2016-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-006	8709491	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-006	9017731	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-006	9265737	2032-06-28	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204326-006	9839619	2032-06-28	Drug product	2024-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204326-001	8840924	2026-04-09	Drug product	2016-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-001	8709491	2032-06-28	Drug product	2016-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-001	9017731	2032-06-28	Drug product	2016-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-001	9265737	2032-06-28	Drug product	2016-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-001	9839619	2032-06-28	Drug product	2024-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-002	8840924	2026-04-09	Drug product	2016-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-002	8709491	2032-06-28	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-002	9017731	2032-06-28	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-002	9265737	2032-06-28	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204326-002	9839619	2032-06-28	Drug product	2024-04-22	`011fe1cb6892…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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