FDA.reportPublic FDA data

Application 021977

Type
NDA
Sponsor
SHIRE DEVELOPMENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VYVANSELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL30MGYesNo
002VYVANSELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL50MGYesNo
003VYVANSELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL70MGYesYes
004VYVANSELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL20MGYesNo
005VYVANSELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL40MGYesNo
006VYVANSELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL60MGYesNo
007VYVANSELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL10MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59417-101Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-101Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-101Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-101Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-101Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-101Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-102Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-102Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-102Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-102Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-102Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-102Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-103Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-103Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-103Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-103Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-103Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-103Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-104Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-104Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-104Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-104Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-104Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-104Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-105Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-105Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-105Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-105Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-105Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-105Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-106Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-106Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-106Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-106Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-106Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-106Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-107Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-107Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-107Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-107Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent
59417-107Vyvanselisdexamfetamine dimesylateTakeda Pharmaceuticals America, Inc.NDACurrent
59417-107Vyvanselisdexamfetamine dimesylateShire LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85756SUPPL 2026-04-27
85801SUPPL 2026-04-24
85746SUPPL 2026-04-24
83519SUPPL 2025-09-25
83518SUPPL 2025-09-25
83444SUPPL 2025-09-25
75773SUPPL 2023-10-16
75741SUPPL 2023-10-16
75740SUPPL 2023-10-16
70333SUPPL2022-03-01
70332SUPPL2022-03-01
70300SUPPL2022-02-28
69218SUPPL2021-11-03
69217SUPPL2021-11-03
69214SUPPL2021-11-03
68233SUPPL2021-08-02
68228SUPPL2021-07-30
68227SUPPL2021-07-30
49198SUPPL2017-08-02
49177SUPPL2017-08-01
49174SUPPL2017-08-01
48500SUPPL2017-05-23
48487SUPPL2017-05-23
47092SUPPL2017-01-31
47045SUPPL2017-01-31
46848SUPPL2017-01-17
46768SUPPL2017-01-09
45559SUPPL2016-10-19
45558SUPPL2016-10-19
45619SUPPL2016-10-17
45618SUPPL2016-10-17
21892SUPPL2015-05-14
21891SUPPL2015-05-14
16684SUPPL2015-04-21
28968SUPPL2015-04-20
37986SUPPL2015-02-03
16683SUPPL2015-02-03
28967SUPPL2015-02-02
6579SUPPL2015-02-02
16682SUPPL2014-11-20
28966SUPPL2014-11-17
37985SUPPL2014-07-30
16681SUPPL2014-07-30
28965SUPPL2014-07-23
6578SUPPL2014-07-23
16680SUPPL2013-12-12
28964SUPPL2013-12-10
37984SUPPL2013-06-18
6577SUPPL2013-06-18
28963SUPPL2013-04-30
16679SUPPL2013-04-29
37983SUPPL2012-11-26
16678SUPPL2012-11-26
16677SUPPL2012-11-26
28962SUPPL2012-11-21
28961SUPPL2012-11-21
6576SUPPL2012-11-21
6574SUPPL2012-02-03
37981SUPPL2012-02-01
44164ORIG2011-12-20
6575SUPPL2011-09-06
37982SUPPL2011-09-02
37978SUPPL2011-03-21
28957SUPPL2011-03-21
28960SUPPL2010-11-15
28959SUPPL2010-11-15
6573SUPPL2010-11-15
6572SUPPL2010-11-15
37980SUPPL2010-11-12
16676SUPPL2010-11-12
16675SUPPL2010-11-12
16674SUPPL2010-11-12
28958SUPPL2010-04-08
28956SUPPL2010-04-08
37977SUPPL2010-04-05
16673SUPPL2010-04-05
6571SUPPL2010-01-28
37979SUPPL2009-12-11
28955SUPPL2009-05-29
6569SUPPL2009-05-29
37976SUPPL2009-05-25
16672SUPPL2009-05-25
6570SUPPL2008-11-13
37975SUPPL2008-06-05
28954SUPPL2008-04-25
6568SUPPL2008-01-09
16671SUPPL2007-12-14
42366ORIG2007-04-05
6567ORIG2007-03-06
16670ORIG2007-02-26
53328ORIG1900-01-01
53327ORIG1900-01-01
53326ORIG1900-01-01
53325ORIG1900-01-01
51315SUPPL1900-01-01
51314SUPPL1900-01-01