Application 083735

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMPEX	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	5MG	No	No
002	DEXAMPEX	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
A083735-001	DEXAMPEX	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		Approved before 1982
A083735-002	DEXAMPEX	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		Approved before 1982

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 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083735-001	DEXAMPEX	5MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A083735-002	DEXAMPEX	10MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`

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 2 · 23 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	0ef920a9-c5b9-4d31-a478-ee18d22a3c5b	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Aurolife Pharma, LLC	24163442-dd03-4066-a6ed-eb7e292b700b	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	SUNRISE PHARMACEUTICAL, INC.	93b3a40f-b7ac-4047-8ff5-3e34c2d75193	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate Extended-Release	DEXTROAMPHETAMINE SULFATE	SpecGx LLC	69c40af8-3710-46bf-bd3d-137fe5eea23e	2025-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Zenzedi	DEXTROAMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	d6394df5-f2c9-47eb-b57e-f3e9cfd94f84	2025-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	Amneal Pharmaceuticals LLC	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	2025-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	9346ff55-b751-4919-ae63-eb58b69e3f0f	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	54b122b0-2ec8-43c9-86e8-a3538a83c776	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	9f1c9cb0-7752-40cc-8ed1-5e79b8dc9da2	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	fc164327-dd48-4851-b613-71d957ee6066	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	b40c9a90-7e2e-48d6-adb6-2351c0ca621d	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	SpecGx LLC	e05cf690-d45a-4696-a1bf-40c9350cc084	2025-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Winder Laboratories LLC	ca1a8890-0675-4c9c-9716-6c28f975d827	2025-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Wilshire Pharmaceuticals, Inc.	6b8c97ac-c83c-4a1f-a33c-121239253abf	2025-06-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Teva Pharmaceuticals USA, Inc.	ec2d13f3-d14f-47e4-abe9-7763f95a8e94	2025-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Cranbury Pharmaceuticals, LLC	9acdf000-fefe-47c7-a44c-0f7a65c5c05c	2025-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
PROCENTRA	DEXTROAMPHETAMINE SULFATE	INDEPENDENCE PHARMACEUTICALS, LLC	1548cce2-fb6b-4f17-8a3b-868933f6c9d6	2025-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Prasco Laboratories	94674695-aa8a-3150-e053-2995a90a445f	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	c706a849-9df6-43ca-9ac6-1d9ce6b8e855	2024-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	5c493bef-0c3e-49f5-b55a-f1446094f5da	2024-09-06	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.