Application 040776

Type: ANDA
Sponsor: OUTLOOK PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	SOLUTION;ORAL	5MG/5ML	No	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040776-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040776-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A040776-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040776-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040776-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040776-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040776-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040776-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040776-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040776-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040776-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040776-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040776-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040776-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040776-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040776-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040776-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040776-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040776-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040776-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040776-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040776-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040776-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040776-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040776-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040776-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040776-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040776-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040776-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040776-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040776-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040776-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040776-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040776-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040776-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040776-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040776-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040776-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040776-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040776-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040776-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040776-001	AA	1	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCENTRA	DEXTROAMPHETAMINE SULFATE	INDEPENDENCE PHARMACEUTICALS, LLC	1548cce2-fb6b-4f17-8a3b-868933f6c9d6	2025-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040776 application number: ANDA040776 ndc (product): 21724-701
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Prasco Laboratories	94674695-aa8a-3150-e053-2995a90a445f	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040776 application number: ANDA040776 ndc (product): 66993-359

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13551-701	ProCentra	dextroamphetamine sulfate	FSC Laboratories, Inc	ANDA	Current
21724-701	Procentra	dextroamphetamine sulfate	Independence Pharmaceuticals, LLC	ANDA	Current
21724-701	Procentra	dextroamphetamine sulfate	Independence Pharmaceuticals, LLC	ANDA	Current
21724-701	Procentra	dextroamphetamine sulfate	Independence Pharmaceuticals, LLC	ANDA	Current
46672-646	dextroamphetamine sulfate	dextroamphetamine sulfate	Mikart, Inc.	ANDA	Current
46672-646	dextroamphetamine sulfate	dextroamphetamine sulfate	Mikart, LLC	ANDA	Current
66993-359	dextroamphetamine sulfate	dextroamphetamine sulfate	Prasco Laboratories	ANDA	Current
66993-359	dextroamphetamine sulfate	dextroamphetamine sulfate	Prasco Laboratories	ANDA	Current
66993-359	dextroamphetamine sulfate	dextroamphetamine sulfate	Prasco Laboratories	ANDA	Current
76181-002	dextroamphetamine sulfate	dextroamphetamine sulfate	Avadel Generics, LLC	ANDA	Current
76181-002	dextroamphetamine sulfate	dextroamphetamine sulfate	Avadel Generics, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42637	ORIG	2013-01-24
23420	ORIG	2008-02-28