Application 021303

Type: NDA
Sponsor: SHIRE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADDERALL XR 10	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	2.5MG;2.5MG;2.5MG;2.5MG	Yes	No
002	ADDERALL XR 20	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	5MG;5MG;5MG;5MG	Yes	No
003	ADDERALL XR 30	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	7.5MG;7.5MG;7.5MG;7.5MG	Yes	Yes
004	ADDERALL XR 25	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	6.25MG;6.25MG;6.25MG;6.25MG	Yes	No
005	ADDERALL XR 5	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	1.25MG;1.25MG;1.25MG;1.25MG	Yes	No
006	ADDERALL XR 15	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	3.75MG;3.75MG;3.75MG;3.75MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021303-001	ADDERALL XR 10	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11
N021303-002	ADDERALL XR 20	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11
N021303-003	ADDERALL XR 30	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11
N021303-004	ADDERALL XR 25	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22
N021303-005	ADDERALL XR 5	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22
N021303-006	ADDERALL XR 15	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021303-001	AB1
N021303-002	AB1
N021303-003	AB1
N021303-004	AB1
N021303-005	AB1
N021303-006	AB1

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 7 · 246 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	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	N021303-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-006	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-004	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-005	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-006	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021303-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-004	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-005	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-006	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-004	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-005	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-006	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-004	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-005	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-006	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-004	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-005	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-006	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-004	AB1	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021303-001	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-001	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-001	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-001	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021303-001	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-001	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-001	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-001	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adderall XR	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE	Takeda Pharmaceuticals America, Inc.	aff45863-ffe1-4d4f-8acf-c7081512a6c0	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021303 application number: NDA021303 ndc (product): 54092-387 ndc (product): 54092-391 ndc (product): 54092-389
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE	Sandoz Inc	6f637e8d-7c2e-47fa-a43c-3250c51aed77	2023-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021303 application number: NDA021303
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE	Prasco Laboratories	f85af6ee-9029-42de-adea-6dbb8642952c	2023-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021303 application number: NDA021303 ndc (product): 66993-596 ndc (product): 66993-598 ndc (product): 66993-599 ndc (product): 66993-595 ndc (product): 66993-597 ndc (product): 66993-594

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 120 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54092-387	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-387	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-387	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Shire US Manufacturing Inc.	NDA	Current
54092-387	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-389	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-389	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Shire US Manufacturing Inc.	NDA	Current
54092-389	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-389	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-389	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Shire US Manufacturing Inc.	NDA	Current
54092-389	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-391	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-391	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Shire US Manufacturing Inc.	NDA	Current
54092-391	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-391	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-391	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Shire US Manufacturing Inc.	NDA	Current
54092-391	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	Takeda Pharmaceuticals America, Inc.	NDA	Current
66993-594	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-594	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-594	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-594	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-595	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-595	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-595	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-595	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-596	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-596	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-596	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-596	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-597	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-597	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-597	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-597	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-598	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-598	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-598	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-598	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-599	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-599	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-599	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-599	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85755	SUPPL	2026-04-27
85802	SUPPL	2026-04-24
85744	SUPPL	2026-04-24
83507	SUPPL	2025-09-25
83439	SUPPL	2025-09-25
75775	SUPPL	2023-10-16
75738	SUPPL	2023-10-16
70345	SUPPL	2022-03-01
70344	SUPPL	2022-03-01
70299	SUPPL	2022-02-28
59269	SUPPL	2019-07-08
59268	SUPPL	2019-07-08
54931	SUPPL	2018-07-20
54907	SUPPL	2018-07-17
48426	SUPPL	2017-05-17
48425	SUPPL	2017-05-17
46846	SUPPL	2017-01-17
46769	SUPPL	2017-01-09
36620	SUPPL	2015-04-21
27429	SUPPL	2015-04-21
15147	SUPPL	2014-07-28
4974	SUPPL	2014-07-25
27428	SUPPL	2013-12-05
36619	SUPPL	2013-12-04
15146	SUPPL	2013-06-18
4973	SUPPL	2013-06-18
36618	SUPPL	2013-03-12
27427	SUPPL	2013-03-11
27426	SUPPL	2012-02-10
36617	SUPPL	2012-02-09
27425	SUPPL	2010-11-18
4972	SUPPL	2010-11-18
36616	SUPPL	2010-11-17
15145	SUPPL	2010-11-17
27424	SUPPL	2008-11-13
21583	SUPPL	2007-06-22
15144	SUPPL	2007-05-29
4971	SUPPL	2007-05-29
27423	SUPPL	2006-07-27
15143	SUPPL	2006-07-27
27422	SUPPL	2006-06-20
15142	SUPPL	2006-06-20
27421	SUPPL	2005-07-26
15141	SUPPL	2005-07-26
23643	ORIG	2005-04-15
15140	SUPPL	2005-02-07
27420	SUPPL	2004-08-12
21582	ORIG	2004-05-25
15139	SUPPL	2002-05-22
4970	SUPPL	2002-05-22
36615	ORIG	2001-10-11
4969	ORIG	2001-10-11
52049	SUPPL	1900-01-01
52048	SUPPL	1900-01-01
52047	SUPPL	1900-01-01
52046	SUPPL	1900-01-01
52045	SUPPL	1900-01-01
52044	SUPPL	1900-01-01