Application 203901

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

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

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

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	Approval date
A203901-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30
A203901-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30
A203901-003	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203901-001	AB
A203901-002	AB
A203901-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A203901-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203901-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203901-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203901-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203901-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203901-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203901-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203901-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203901-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203901-001	AB	1	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dextroamphetamine sulfate	DEXTROAMPHETAMINE SULFATE	Actavis Pharma, Inc.	9e92ccc3-d81c-461d-a19f-7e9b582be357	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203901 application number: ANDA203901 ndc (product): 45963-304 ndc (product): 45963-305 ndc (product): 45963-303

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45963-303	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-303	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-303	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-303	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-303	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-303	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-304	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-304	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-304	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-304	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-304	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-304	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-305	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-305	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-305	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-305	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-305	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
45963-305	dextroamphetamine sulfate	dextroamphetamine sulfate	Actavis Pharma, Inc.	ANDA	Current
51862-344	dextroamphetamine sulfate	dextroamphetamine sulfate	Mayne Pharma Inc.	ANDA	Current
51862-344	dextroamphetamine sulfate	dextroamphetamine sulfate	Mayne Pharma Inc.	ANDA	Current
51862-344	dextroamphetamine sulfate	dextroamphetamine sulfate	Mayne Pharma Inc.	ANDA	Current
51862-345	dextroamphetamine sulfate	dextroamphetamine sulfate	Mayne Pharma Inc.	ANDA	Current
51862-345	dextroamphetamine sulfate	dextroamphetamine sulfate	Mayne Pharma Inc.	ANDA	Current
51862-345	dextroamphetamine sulfate	dextroamphetamine sulfate	Mayne Pharma Inc.	ANDA	Current
51862-346	dextroamphetamine sulfate	dextroamphetamine sulfate	Mayne Pharma Inc.	ANDA	Current
51862-346	dextroamphetamine sulfate	dextroamphetamine sulfate	Mayne Pharma Inc.	ANDA	Current
51862-346	dextroamphetamine sulfate	dextroamphetamine sulfate	Mayne Pharma Inc.	ANDA	Current