Application 206588

Type: ANDA
Sponsor: NESHER PHARMS

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 43.

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
A206588-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL			2016-03-28
A206588-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL			2016-03-28

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 · 86 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
2026-09-14 22:38:34	2026-08	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2016-03-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2016-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2016-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2016-03-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A206588-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206588-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206588-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206588-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206588-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206588-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206588-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206588-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206588-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206588-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206588-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206588-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206588-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206588-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206588-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206588-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206588-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206588-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206588-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206588-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206588-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206588-002	AA	1	`ea99ee380514…`

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	5c493bef-0c3e-49f5-b55a-f1446094f5da	2024-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DEXTROAMPHETAMINE SULFATE generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Lupin Pharmaceuticals,Inc.	9aea6b7c-729c-484d-b625-c3591b63b350	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Dextroamphetamine Sulfate generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	KVK-Tech, Inc.	863d66fe-9c38-463a-afa1-552647494c5a	2024-01-17	Warnings, Adverse reactions	Name fallback brand name: Dextroamphetamine Sulfate generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate Extended-Release	DEXTROAMPHETAMINE SULFATE	Amneal Pharmaceuticals of New York LLC	2ec5c30f-4eb8-48a5-83c4-236450413464	2023-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-941	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-941	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-941	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-942	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-942	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-942	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current