Application 017078

Type: NDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXEDRINE	DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	5MG	Yes	No
002	DEXEDRINE	DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	No
003	DEXEDRINE	DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N017078-001	DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982
N017078-002	DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982
N017078-003	DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N017078-001	AB
N017078-002	AB
N017078-003	AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-001	DEXEDRINE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-002	DEXEDRINE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-003	DEXEDRINE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-001	DEXEDRINE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-002	DEXEDRINE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-003	DEXEDRINE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017078-001	DEXEDRINE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N017078-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017078-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017078-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017078-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017078-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017078-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017078-001	AB	1	`1e350fbaab3a…`

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
DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	Amneal Pharmaceuticals LLC	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017078 application number: NDA017078 ndc (product): 64896-675 ndc (product): 64896-673 ndc (product): 64896-674
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	Exact identifier application applno (NDA): 017078 application number: NDA017078 ndc (product): 0115-9929 ndc (product): 0115-9927 ndc (product): 0115-9928

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1702	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1702	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1702	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1703	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1703	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1703	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1704	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1704	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1704	Dextroamphetamine SulfateExtended-Release	Dextroamphetamine Sulfate	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-9927	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-9927	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-9927	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-9927	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-9928	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-9928	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-9928	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-9928	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-9929	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-9929	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-9929	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-9929	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Impax Generics	NDA AUTHORIZED GENERIC	Current
52054-512	DEXEDRINE	dextroamphetamine sulfate	Amedra Pharmaceuticals LLC	NDA	Current
52054-513	DEXEDRINE	dextroamphetamine sulfate	Amedra Pharmaceuticals LLC	NDA	Current
52054-514	DEXEDRINE	dextroamphetamine sulfate	Amedra Pharmaceuticals LLC	NDA	Current
54505-327	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Lineage Therapeutics Inc	NDA AUTHORIZED GENERIC	Current
54505-328	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Lineage Therapeutics Inc	NDA AUTHORIZED GENERIC	Current
54505-329	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Lineage Therapeutics Inc	NDA AUTHORIZED GENERIC	Current
64896-673	DEXEDRINE	dextroamphetamine sulfate	Amneal Pharmaceuticals LLC	NDA	Current
64896-673	DEXEDRINE	dextroamphetamine sulfate	Amneal Pharmaceuticals LLC	NDA	Current
64896-673	DEXEDRINE	dextroamphetamine sulfate	Amneal Pharmaceuticals LLC	NDA	Current
64896-673	DEXEDRINE	dextroamphetamine sulfate	Impax Specialty Pharma	NDA	Current
64896-674	DEXEDRINE	dextroamphetamine sulfate	Amneal Pharmaceuticals LLC	NDA	Current
64896-674	DEXEDRINE	dextroamphetamine sulfate	Amneal Pharmaceuticals LLC	NDA	Current
64896-674	DEXEDRINE	dextroamphetamine sulfate	Amneal Pharmaceuticals LLC	NDA	Current
64896-674	DEXEDRINE	dextroamphetamine sulfate	Impax Specialty Pharma	NDA	Current
64896-675	DEXEDRINE	dextroamphetamine sulfate	Amneal Pharmaceuticals LLC	NDA	Current
64896-675	DEXEDRINE	dextroamphetamine sulfate	Amneal Pharmaceuticals LLC	NDA	Current
64896-675	DEXEDRINE	dextroamphetamine sulfate	Amneal Pharmaceuticals LLC	NDA	Current
64896-675	DEXEDRINE	dextroamphetamine sulfate	Impax Specialty Pharma	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83456	SUPPL	2025-09-25
83455	SUPPL	2025-09-25
83423	SUPPL	2025-09-24
75784	SUPPL	2023-10-17
75770	SUPPL	2023-10-16
70327	SUPPL	2022-03-01
70326	SUPPL	2022-03-01
70285	SUPPL	2022-02-28
57313	SUPPL	2019-01-22
57225	SUPPL	2019-01-16
57224	SUPPL	2019-01-16
56340	SUPPL	2018-11-08
48506	SUPPL	2017-05-24
48481	SUPPL	2017-05-22
46775	SUPPL	2017-01-10
46716	SUPPL	2017-01-06
13081	SUPPL	2015-04-20
10960	SUPPL	2015-04-20
10959	SUPPL	2013-12-12
542	SUPPL	2013-12-10
10958	SUPPL	2013-06-18
541	SUPPL	2013-06-13
33224	SUPPL	2008-06-12
13080	SUPPL	2008-05-28
44010	ORIG	2007-05-18
33223	SUPPL	2007-05-07
540	SUPPL	2007-05-07
539	SUPPL	2006-08-14
10957	SUPPL	2006-08-11