Application 200166

Type: ANDA
Sponsor: ARBOR PHARMS LLC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A200166-001	EVEKEO	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA		2012-08-09
A200166-002	EVEKEO	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	RS	2012-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200166-001	AA
A200166-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200166-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200166-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200166-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200166-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200166-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200166-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200166-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200166-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200166-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200166-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200166-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200166-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200166-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200166-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200166-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200166-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200166-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200166-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200166-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200166-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200166-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200166-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200166-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200166-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200166-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200166-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200166-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200166-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200166-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200166-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200166-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200166-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200166-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200166-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200166-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200166-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200166-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200166-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200166-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200166-002	AA	1	`782e0a99824c…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amphetamine Sulfate	AMPHETAMINE SULFATE	Bryant Ranch Prepack	b94e2562-fd19-455f-ac10-2cc24302d27a	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166
Amphetamine Sulfate	AMPHETAMINE SULFATE	Bryant Ranch Prepack	920f99f4-ab78-4eed-9d80-08a2ebd0b769	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166
Amphetamine Sulfate	AMPHETAMINE SULFATE	Wilshire Pharmaceuticals, Inc.	91add2e3-8359-47dc-b79f-197d36b02819	2025-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166 ndc (product): 52536-059 ndc (product): 52536-057
Evekeo	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	f469fb38-0380-4621-9db3-a4f429126156	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166 ndc (product): 24338-026 ndc (product): 24338-022
Amphetamine Sulfate	AMPHETAMINE SULFATE	Bryant Ranch Prepack	674940ec-1714-4e41-b471-2a8c8a6c5ade	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166 ndc (product): 63629-2499
Amphetamine Sulfate	AMPHETAMINE SULFATE	Bryant Ranch Prepack	c972a6a4-a96c-4d70-b4c4-eef9e990abb4	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166 ndc (product): 63629-2498

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24338-022	Evekeo	Amphetamine Sulfate	Arbor Pharmaceuticals	ANDA	Current
24338-022	Evekeo	Amphetamine Sulfate	Arbor Pharmaceuticals	ANDA	Current
24338-022	Evekeo	Amphetamine Sulfate	Arbor Pharmaceuticals	ANDA	Current
24338-022	Evekeo	Amphetamine Sulfate	Arbor Pharmaceuticals	ANDA	Current
24338-022	Evekeo	Amphetamine Sulfate	Arbor Pharmaceuticals	ANDA	Current
24338-026	Evekeo	Amphetamine Sulfate	Arbor Pharmaceuticals	ANDA	Current
24338-026	Evekeo	Amphetamine Sulfate	Arbor Pharmaceuticals	ANDA	Current
24338-026	Evekeo	Amphetamine Sulfate	Arbor Pharmaceuticals	ANDA	Current
24338-026	Evekeo	Amphetamine Sulfate	Arbor Pharmaceuticals	ANDA	Current
24338-026	Evekeo	Amphetamine Sulfate	Arbor Pharmaceuticals	ANDA	Current
52536-057	Amphetamine Sulfate	Amphetamine Sulfate	Wilshire Pharmaceuticals	ANDA	Current
52536-057	Amphetamine Sulfate	Amphetamine Sulfate	Wilshire Pharmaceuticals	ANDA	Current
52536-057	Amphetamine Sulfate	Amphetamine Sulfate	Wilshire Pharmaceuticals	ANDA	Current
52536-059	Amphetamine Sulfate	Amphetamine Sulfate	Wilshire Pharmaceuticals	ANDA	Current
52536-059	Amphetamine Sulfate	Amphetamine Sulfate	Wilshire Pharmaceuticals	ANDA	Current
52536-059	Amphetamine Sulfate	Amphetamine Sulfate	Wilshire Pharmaceuticals	ANDA	Current
63629-2498	Amphetamine Sulfate	Amphetamine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2498	Amphetamine Sulfate	Amphetamine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2498	Amphetamine Sulfate	Amphetamine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2499	Amphetamine Sulfate	Amphetamine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2499	Amphetamine Sulfate	Amphetamine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2499	Amphetamine Sulfate	Amphetamine Sulfate	Bryant Ranch Prepack	ANDA	Current