Application 210526

Type: NDA
Sponsor: TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DYANAVEL XR	AMPHETAMINE	TABLET, EXTENDED RELEASE;ORAL	5MG	No	No
002	DYANAVEL XR	AMPHETAMINE	TABLET, EXTENDED RELEASE; ORAL	10MG	No	No
003	DYANAVEL XR	AMPHETAMINE	TABLET, EXTENDED RELEASE;ORAL	15MG	No	No
004	DYANAVEL XR	AMPHETAMINE	TABLET, EXTENDED RELEASE; ORAL	20MG	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
N210526-001	DYANAVEL XR 5	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04
N210526-002	DYANAVEL XR 10	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04
N210526-003	DYANAVEL XR 15	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04
N210526-004	DYANAVEL XR 20	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210526-001	8337890	2027-03-15		Drug product	2021-11-22
N210526-001	8747902	2027-03-15		Drug product	2021-11-22
N210526-001	9675704	2027-03-15		Drug product	2021-11-22
N210526-001	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-001	12458592	2040-02-11	U-3538		2025-11-14
N210526-002	8337890	2027-03-15		Drug product	2021-11-22
N210526-002	8747902	2027-03-15		Drug product	2021-11-22
N210526-002	9675704	2027-03-15		Drug product	2021-11-22
N210526-002	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-002	12458592	2040-02-11	U-3538		2025-11-14
N210526-003	8337890	2027-03-15		Drug product	2021-11-22
N210526-003	8747902	2027-03-15		Drug product	2021-11-22
N210526-003	9675704	2027-03-15		Drug product	2021-11-22
N210526-003	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-003	12458592	2040-02-11	U-3538		2025-11-14
N210526-004	8337890	2027-03-15		Drug product	2021-11-22
N210526-004	8747902	2027-03-15		Drug product	2021-11-22
N210526-004	9675704	2027-03-15		Drug product	2021-11-22
N210526-004	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-004	12458592	2040-02-11	U-3538		2025-11-14

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 500 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210526-001	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dyanavel XR	AMPHETAMINE	NextWave Pharmaceuticals, Inc	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210526 application number: NDA210526 ndc (product): 24478-109 ndc (product): 24478-110 ndc (product): 24478-108 ndc (product): 24478-106

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24478-106	DYANAVEL XR	amphetamine	NextWave Pharmaceuticals, Inc	NDA	Current
24478-108	DYANAVEL XR	amphetamine	NextWave Pharmaceuticals, Inc	NDA	Current
24478-109	DYANAVEL XR	amphetamine	NextWave Pharmaceuticals, Inc	NDA	Current
24478-110	DYANAVEL XR	amphetamine	NextWave Pharmaceuticals, Inc	NDA	Current
27808-106	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current
27808-106	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current
27808-106	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current
27808-108	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current
27808-108	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current
27808-108	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current
27808-109	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current
27808-109	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current
27808-109	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current
27808-110	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current
27808-110	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current
27808-110	DYANAVEL XR	amphetamine	Tris Pharma Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83496	SUPPL	2025-09-25
83495	SUPPL	2025-09-25
83452	SUPPL	2025-09-25
75789	SUPPL	2023-10-17
75769	SUPPL	2023-10-16
72352	SUPPL	2022-10-17
71213	SUPPL	2022-06-06
71204	SUPPL	2022-06-02
70567	ORIG	2022-03-21
70380	SUPPL	2022-03-02
70379	SUPPL	2022-03-02
70296	SUPPL	2022-02-28
69271	ORIG	2021-11-08
69270	ORIG	2021-11-08
69269	ORIG	2021-11-08