Application 210059

Type: ANDA
Sponsor: NUVO PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	5MG	No	No
002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210059-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA		2017-10-18
A210059-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA		2017-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210059-001	AA
A210059-002	AA

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A210059-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210059-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210059-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210059-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210059-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210059-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210059-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210059-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210059-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210059-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210059-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210059-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210059-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210059-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210059-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210059-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210059-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210059-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210059-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210059-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210059-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210059-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210059-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210059-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210059-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210059-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210059-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210059-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210059-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210059-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210059-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210059-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210059-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210059-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210059-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210059-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210059-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210059-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210059-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210059-002	AA	1	`bb7c543d1eb4…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	SUNRISE PHARMACEUTICAL, INC.	93b3a40f-b7ac-4047-8ff5-3e34c2d75193	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210059 application number: ANDA210059 ndc (product): 11534-189 ndc (product): 11534-188
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	466cbae8-4f67-4a65-b670-ada6a953d550	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210059 application number: ANDA210059 ndc (product): 63629-2375
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	0ef920a9-c5b9-4d31-a478-ee18d22a3c5b	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210059 application number: ANDA210059 ndc (product): 63629-2374
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	c706a849-9df6-43ca-9ac6-1d9ce6b8e855	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210059 application number: ANDA210059
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	5c493bef-0c3e-49f5-b55a-f1446094f5da	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210059 application number: ANDA210059

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
11534-188	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-188	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-188	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-188	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-188	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-188	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-189	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-189	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-189	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-189	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-189	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-189	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
63629-2374	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2374	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2375	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2375	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	Bryant Ranch Prepack	ANDA	Current