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

NDC Listings For This Application#

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	Shire LLC	NDA	Current
59417-115	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-115	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-115	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	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
59417-117	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	Shire LLC	NDA	Current
59417-118	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-118	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Shire LLC	NDA	Current
59417-118	Vyvanse	LISDEXAMFETAMINE DIMESYLATE	Takeda Pharmaceuticals America, Inc.	NDA	Current
59417-118	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	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

Application 208510

Related Records#

Application Products#

NDC Listings For This Application#

Documents#