Application 208510

Type: NDA
Sponsor: SHIRE DEV LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	10MG	Yes	No
002	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	20MG	Yes	No
003	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	30MG	Yes	No
004	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	40MG	Yes	No
005	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	50MG	Yes	No
006	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	TABLET, CHEWABLE;ORAL	60MG	Yes	Yes

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
N208510-001	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	10MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28
N208510-002	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	20MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28
N208510-003	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	30MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28
N208510-004	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	40MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28
N208510-005	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	50MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28
N208510-006	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	60MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2017-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208510-001	AB
N208510-002	AB
N208510-003	AB
N208510-004	AB
N208510-005	AB
N208510-006	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 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	N208510-001	VYVANSE	10MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208510-002	VYVANSE	20MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208510-003	VYVANSE	30MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208510-004	VYVANSE	40MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208510-005	VYVANSE	50MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208510-006	VYVANSE	60MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2017-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-001	VYVANSE	10MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-002	VYVANSE	20MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-003	VYVANSE	30MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-004	VYVANSE	40MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-005	VYVANSE	50MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-006	VYVANSE	60MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2017-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208510-001	VYVANSE	10MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208510-002	VYVANSE	20MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208510-003	VYVANSE	30MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208510-004	VYVANSE	40MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208510-005	VYVANSE	50MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208510-006	VYVANSE	60MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2017-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-001	VYVANSE	10MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-002	VYVANSE	20MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-003	VYVANSE	30MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-004	VYVANSE	40MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-005	VYVANSE	50MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-006	VYVANSE	60MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2017-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-001	VYVANSE	10MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-002	VYVANSE	20MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-003	VYVANSE	30MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-004	VYVANSE	40MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-005	VYVANSE	50MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-006	VYVANSE	60MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2017-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-001	VYVANSE	10MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-002	VYVANSE	20MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-003	VYVANSE	30MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-004	VYVANSE	40MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-005	VYVANSE	50MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-006	VYVANSE	60MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2017-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208510-001	VYVANSE	10MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208510-002	VYVANSE	20MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208510-003	VYVANSE	30MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208510-004	VYVANSE	40MG	TABLET, CHEWABLE / ORAL	AB	RLD	2017-01-28	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	N208510-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208510-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208510-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208510-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208510-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208510-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208510-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208510-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208510-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208510-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208510-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208510-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208510-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208510-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208510-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208510-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208510-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208510-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208510-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208510-004	AB	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 102 · 4,080 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7105486	2023-02-24	U-727		2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7223735	2023-02-24		Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7655630	2023-02-24		Drug substance, Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7659253	2023-02-24	U-727	Drug substance, Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7659254	2023-02-24	U-727		2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7662787	2023-02-24		Drug substance	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7662788	2023-02-24	U-727		2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7671030	2023-02-24	U-727	Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7671031	2023-02-24	U-727		2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7674774	2023-02-24	U-727	Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7678770	2023-02-24	U-727		2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7678771	2023-02-24	U-727	Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7687466	2023-02-24		Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7687467	2023-02-24	U-727	Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7713936	2023-02-24	U-727		2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7718619	2023-02-24	U-727	Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7723305	2023-02-24	U-727	Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7105486*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7223735*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7655630*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7659253*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7659254*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7662787*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7662788*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7671030*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7671031*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7674774*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7678770*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7678771*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7687466*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7687467*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7713936*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7718619*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-001	7723305*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-002	7105486	2023-02-24	U-727		2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-002	7223735	2023-02-24		Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-002	7655630	2023-02-24		Drug substance, Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-002	7659253	2023-02-24	U-727	Drug substance, Drug product	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-002	7659254	2023-02-24	U-727		2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208510-002	7662787	2023-02-24		Drug substance	2017-02-27	`5c6f7cd8ea54…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208510-001	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208510-002	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208510-003	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208510-004	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208510-005	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208510-006	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208510-001	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208510-002	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208510-003	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208510-004	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208510-005	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208510-006	M-188	2019-10-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208510-001	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208510-002	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208510-003	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208510-004	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208510-005	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208510-006	M-188	2019-10-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208510-001	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208510-002	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208510-003	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208510-004	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208510-005	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208510-006	M-188	2019-10-14	`ea99ee380514…`

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
Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	704e4378-ca83-445c-8b45-3cfa51c1ecad	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208510 application number: NDA208510 ndc (product): 59417-119 ndc (product): 59417-116 ndc (product): 59417-117 ndc (product): 59417-118 ndc (product): 59417-115 ndc (product): 59417-120

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59417-115	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-115	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-115	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-115	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-115	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-115	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-116	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-116	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-116	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-116	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-116	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-116	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-117	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-117	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-117	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-117	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-117	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-117	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-118	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-118	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-118	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-118	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-118	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-118	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-119	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-119	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-119	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-119	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-119	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-119	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-120	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-120	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-120	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-120	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-120	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-120	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85758	SUPPL	2026-04-27
85803	SUPPL	2026-04-24
85750	SUPPL	2026-04-24
83521	SUPPL	2025-09-25
83520	SUPPL	2025-09-25
83445	SUPPL	2025-09-25
75774	SUPPL	2023-10-16
75742	SUPPL	2023-10-16
70335	SUPPL	2022-03-01
70334	SUPPL	2022-03-01
70302	SUPPL	2022-02-28
69220	SUPPL	2021-11-03
69219	SUPPL	2021-11-03
69215	SUPPL	2021-11-03
68234	SUPPL	2021-08-02
68230	SUPPL	2021-07-30
68229	SUPPL	2021-07-30
50056	ORIG	2017-10-13
49199	SUPPL	2017-08-02
49176	SUPPL	2017-08-01
49175	SUPPL	2017-08-01
48499	SUPPL	2017-05-23
48489	SUPPL	2017-05-23
47073	ORIG	2017-01-31
47037	ORIG	2017-01-27
51313	ORIG	1900-01-01
51312	ORIG	1900-01-01