Application 022063

Type: NDA
Sponsor: SHIRE DEV LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	3.125MG;3.125MG;3.125MG;3.125MG	Yes	No
002	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	6.25MG;6.25MG;6.25MG;6.25MG	Yes	No
003	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	9.375MG;9.375MG;9.375MG;9.375MG	Yes	No
004	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	12.5MG;12.5MG;12.5MG;12.5MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022063-001	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20
N022063-002	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20
N022063-003	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20
N022063-004	MYDAYIS	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022063-001	AB2
N022063-002	AB2
N022063-003	AB2
N022063-004	AB2

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022063-001	9173857	2026-05-12	U-2025		2017-07-07
N022063-001	8846100	2029-08-24		Drug product	2017-07-07
N022063-002	9173857	2026-05-12	U-2025		2017-07-07
N022063-002	8846100	2029-08-24		Drug product	2017-07-07
N022063-003	9173857	2026-05-12	U-2025		2017-07-07
N022063-003	8846100	2029-08-24		Drug product	2017-07-07
N022063-004	9173857	2026-05-12	U-2025		2017-07-07
N022063-004	8846100	2029-08-24		Drug product	2017-07-07

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 5 · 164 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	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022063-001	MYDAYIS	3.125MG;3.125MG;3.125MG;3.125MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-002	MYDAYIS	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-003	MYDAYIS	9.375MG;9.375MG;9.375MG;9.375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2017-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-004	MYDAYIS	12.5MG;12.5MG;12.5MG;12.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2017-06-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	N022063-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-004	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-004	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022063-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-004	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-004	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-004	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022063-004	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022063-004	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-003	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022063-004	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-003	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022063-004	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022063-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-003	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022063-004	AB2	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 424 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022063-001	9173857	2026-05-12	U-2025		2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-001	8846100	2029-08-24		Drug product	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-002	9173857	2026-05-12	U-2025		2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-002	8846100	2029-08-24		Drug product	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-003	9173857	2026-05-12	U-2025		2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-003	8846100	2029-08-24		Drug product	2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-004	9173857	2026-05-12	U-2025		2017-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022063-004	8846100	2029-08-24		Drug product	2017-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-001	9173857	2026-05-12	U-2025		2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-001	8846100	2029-08-24		Drug product	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-002	9173857	2026-05-12	U-2025		2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-002	8846100	2029-08-24		Drug product	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-003	9173857	2026-05-12	U-2025		2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-003	8846100	2029-08-24		Drug product	2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-004	9173857	2026-05-12	U-2025		2017-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022063-004	8846100	2029-08-24		Drug product	2017-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022063-001	9173857	2026-05-12	U-2025		2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-001	8846100	2029-08-24		Drug product	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-002	9173857	2026-05-12	U-2025		2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-002	8846100	2029-08-24		Drug product	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-003	9173857	2026-05-12	U-2025		2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-003	8846100	2029-08-24		Drug product	2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-004	9173857	2026-05-12	U-2025		2017-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022063-004	8846100	2029-08-24		Drug product	2017-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-001	9173857	2026-05-12	U-2025		2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-001	8846100	2029-08-24		Drug product	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-002	9173857	2026-05-12	U-2025		2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-002	8846100	2029-08-24		Drug product	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-003	9173857	2026-05-12	U-2025		2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-003	8846100	2029-08-24		Drug product	2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-004	9173857	2026-05-12	U-2025		2017-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022063-004	8846100	2029-08-24		Drug product	2017-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-001	9173857	2026-05-12	U-2025		2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-001	8846100	2029-08-24		Drug product	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-002	9173857	2026-05-12	U-2025		2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-002	8846100	2029-08-24		Drug product	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-003	9173857	2026-05-12	U-2025		2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-003	8846100	2029-08-24		Drug product	2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-004	9173857	2026-05-12	U-2025		2017-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022063-004	8846100	2029-08-24		Drug product	2017-07-07	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-001	M-248	2022-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-001	PED	2023-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-002	M-248	2022-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-002	PED	2023-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-003	M-248	2022-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-003	PED	2023-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-004	M-248	2022-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022063-004	PED	2023-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022063-001	M-248	2022-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-001	PED	2023-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-002	M-248	2022-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-002	PED	2023-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-003	M-248	2022-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-003	PED	2023-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-004	M-248	2022-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022063-004	PED	2023-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022063-001	M-248	2022-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-001	PED	2023-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-002	M-248	2022-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-002	PED	2023-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-003	M-248	2022-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-003	PED	2023-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-004	M-248	2022-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022063-004	PED	2023-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022063-001	NP	2020-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022063-002	NP	2020-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022063-003	NP	2020-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022063-004	NP	2020-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022063-001	M-248	2022-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-001	PED	2023-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-002	M-248	2022-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-002	PED	2023-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-003	M-248	2022-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-003	PED	2023-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-004	M-248	2022-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022063-004	PED	2023-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022063-001	M-248	2022-09-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022063-001	PED	2023-03-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022063-002	M-248	2022-09-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022063-002	PED	2023-03-13	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AND AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	141a7970-3f06-44ea-9ab7-aeece2c085fc	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022063 application number: NDA022063 ndc (product): 54092-471 ndc (product): 54092-468 ndc (product): 54092-477 ndc (product): 54092-474

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54092-468	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-468	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-468	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current
54092-468	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-468	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current
54092-468	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current
54092-471	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-471	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-471	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current
54092-471	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-471	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current
54092-471	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current
54092-474	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-474	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-474	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current
54092-474	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-474	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current
54092-474	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current
54092-477	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-477	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-477	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current
54092-477	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
54092-477	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current
54092-477	MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	Shire US Manufacturing Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85757	SUPPL	2026-04-27
85804	SUPPL	2026-04-24
85747	SUPPL	2026-04-24
75776	SUPPL	2023-10-16
75737	SUPPL	2023-10-16
75736	SUPPL	2023-10-16
70343	SUPPL	2022-03-01
70342	SUPPL	2022-03-01
70301	SUPPL	2022-02-28
63177	ORIG	2020-05-20
60505	SUPPL	2019-10-09
60363	SUPPL	2019-10-08
60015	SUPPL	2019-09-17
54466	ORIG	2018-06-06
48795	ORIG	2017-06-22
48788	ORIG	2017-06-21
63852	ORIG	1900-01-01
63851	ORIG	1900-01-01
63850	ORIG	1900-01-01
51379	ORIG	1900-01-01
51378	ORIG	1900-01-01
51377	ORIG	1900-01-01