Application 021977

Type: NDA
Sponsor: SHIRE DEVELOPMENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	30MG	Yes	No
002	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	50MG	Yes	No
003	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	70MG	Yes	Yes
004	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	20MG	Yes	No
005	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	40MG	Yes	No
006	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	60MG	Yes	No
007	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	CAPSULE;ORAL	10MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021977-001	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23
N021977-002	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23
N021977-003	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23
N021977-004	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10
N021977-005	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10
N021977-006	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10
N021977-007	VYVANSE	LISDEXAMFETAMINE DIMESYLATE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
N021977-001	AB
N021977-002	AB
N021977-003	AB
N021977-004	AB
N021977-005	AB
N021977-006	AB
N021977-007	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 8 · 287 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	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-006	VYVANSE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-007	VYVANSE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-006	VYVANSE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-007	VYVANSE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-006	VYVANSE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-007	VYVANSE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-006	VYVANSE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-007	VYVANSE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-006	VYVANSE	60MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-007	VYVANSE	10MG	CAPSULE / ORAL	AB	RLD	2014-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-001	VYVANSE	30MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-002	VYVANSE	50MG	CAPSULE / ORAL	AB	RLD	2007-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-003	VYVANSE	70MG	CAPSULE / ORAL	AB	RLD, RS	2007-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-004	VYVANSE	20MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-005	VYVANSE	40MG	CAPSULE / ORAL	AB	RLD	2007-12-10	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 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	N021977-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021977-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021977-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021977-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021977-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021977-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021977-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021977-005	AB	1	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 126 · 5,002 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	N021977-001	7105486	2023-02-24	U-727			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7223735	2023-02-24		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7655630	2023-02-24		Drug substance		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7659253	2023-02-24	U-727	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7659254	2023-02-24	U-1034			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7662787	2023-02-24		Drug substance		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7662788	2023-02-24	U-727		2012-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7671030	2023-02-24	U-727	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7671031	2023-02-24	U-727			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7674774	2023-02-24	U-842	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7678770	2023-02-24	U-842			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7678771	2023-02-24	U-842	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7687466	2023-02-24		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7687467	2023-02-24	U-842	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7700561	2023-02-24		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7713936	2023-02-24	U-727		2012-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7718619	2023-02-24	U-842	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7723305	2023-02-24	U-842	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7105486*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7223735*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7655630*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7659253*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7659254*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7662787*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7662788*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7671030*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7671031*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7674774*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7678770*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7678771*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7687466*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7687467*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7700561*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7713936*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7718619*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-001	7723305*PED	2023-08-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-002	7105486	2023-02-24	U-727			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-002	7223735	2023-02-24		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-002	7655630	2023-02-24		Drug substance		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021977-002	7659253	2023-02-24	U-727	Drug substance, Drug product		`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	N021977-001	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-002	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-003	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-004	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-005	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-006	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021977-007	M-188	2019-10-14	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021977-001	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-002	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-003	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-004	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-005	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-006	M-188	2019-10-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021977-007	M-188	2019-10-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021977-001	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-002	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-003	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-004	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-005	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-006	M-188	2019-10-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021977-007	M-188	2019-10-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021977-001	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-002	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-003	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-004	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-005	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-006	M-188	2019-10-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021977-007	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): 021977 application number: NDA021977 ndc (product): 59417-104 ndc (product): 59417-101 ndc (product): 59417-107 ndc (product): 59417-106 ndc (product): 59417-102 ndc (product): 59417-103 ndc (product): 59417-105

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59417-101	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-101	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-101	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-101	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-101	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-101	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-102	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-102	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-102	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-102	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-102	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-102	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-103	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-103	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-103	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-103	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-103	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-103	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-104	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-104	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-104	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-104	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-104	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-104	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-105	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-105	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-105	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-105	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-105	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-105	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-106	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-106	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-106	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-106	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-106	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-106	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-107	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-107	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-107	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-107	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current
59417-107	Vyvanse	lisdexamfetamine dimesylate	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-107	Vyvanse	lisdexamfetamine dimesylate	Shire LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85756	SUPPL	2026-04-27
85801	SUPPL	2026-04-24
85746	SUPPL	2026-04-24
83519	SUPPL	2025-09-25
83518	SUPPL	2025-09-25
83444	SUPPL	2025-09-25
75773	SUPPL	2023-10-16
75741	SUPPL	2023-10-16
75740	SUPPL	2023-10-16
70333	SUPPL	2022-03-01
70332	SUPPL	2022-03-01
70300	SUPPL	2022-02-28
69218	SUPPL	2021-11-03
69217	SUPPL	2021-11-03
69214	SUPPL	2021-11-03
68233	SUPPL	2021-08-02
68228	SUPPL	2021-07-30
68227	SUPPL	2021-07-30
49198	SUPPL	2017-08-02
49177	SUPPL	2017-08-01
49174	SUPPL	2017-08-01
48500	SUPPL	2017-05-23
48487	SUPPL	2017-05-23
47092	SUPPL	2017-01-31
47045	SUPPL	2017-01-31
46848	SUPPL	2017-01-17
46768	SUPPL	2017-01-09
45559	SUPPL	2016-10-19
45558	SUPPL	2016-10-19
45619	SUPPL	2016-10-17
45618	SUPPL	2016-10-17
21892	SUPPL	2015-05-14
21891	SUPPL	2015-05-14
16684	SUPPL	2015-04-21
28968	SUPPL	2015-04-20
37986	SUPPL	2015-02-03
16683	SUPPL	2015-02-03
28967	SUPPL	2015-02-02
6579	SUPPL	2015-02-02
16682	SUPPL	2014-11-20
28966	SUPPL	2014-11-17
37985	SUPPL	2014-07-30
16681	SUPPL	2014-07-30
28965	SUPPL	2014-07-23
6578	SUPPL	2014-07-23
16680	SUPPL	2013-12-12
28964	SUPPL	2013-12-10
37984	SUPPL	2013-06-18
6577	SUPPL	2013-06-18
28963	SUPPL	2013-04-30
16679	SUPPL	2013-04-29
37983	SUPPL	2012-11-26
16678	SUPPL	2012-11-26
16677	SUPPL	2012-11-26
28962	SUPPL	2012-11-21
28961	SUPPL	2012-11-21
6576	SUPPL	2012-11-21
6574	SUPPL	2012-02-03
37981	SUPPL	2012-02-01
44164	ORIG	2011-12-20
6575	SUPPL	2011-09-06
37982	SUPPL	2011-09-02
37978	SUPPL	2011-03-21
28957	SUPPL	2011-03-21
28960	SUPPL	2010-11-15
28959	SUPPL	2010-11-15
6573	SUPPL	2010-11-15
6572	SUPPL	2010-11-15
37980	SUPPL	2010-11-12
16676	SUPPL	2010-11-12
16675	SUPPL	2010-11-12
16674	SUPPL	2010-11-12
28958	SUPPL	2010-04-08
28956	SUPPL	2010-04-08
37977	SUPPL	2010-04-05
16673	SUPPL	2010-04-05
6571	SUPPL	2010-01-28
37979	SUPPL	2009-12-11
28955	SUPPL	2009-05-29
6569	SUPPL	2009-05-29
37976	SUPPL	2009-05-25
16672	SUPPL	2009-05-25
6570	SUPPL	2008-11-13
37975	SUPPL	2008-06-05
28954	SUPPL	2008-04-25
6568	SUPPL	2008-01-09
16671	SUPPL	2007-12-14
42366	ORIG	2007-04-05
6567	ORIG	2007-03-06
16670	ORIG	2007-02-26
53328	ORIG	1900-01-01
53327	ORIG	1900-01-01
53326	ORIG	1900-01-01
53325	ORIG	1900-01-01
51315	SUPPL	1900-01-01
51314	SUPPL	1900-01-01