FDA.reportPublic FDA data

Application 022287

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXILANTDEXLANSOPRAZOLECAPSULE, DELAYED RELEASE;ORAL30MGYesNo
002DEXILANTDEXLANSOPRAZOLECAPSULE, DELAYED RELEASE;ORAL60MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24979-703DexlansoprazoledexlansoprazoleTWI PHARMACEUTICALS, INC.NDA AUTHORIZED GENERICCurrent
24979-703DexlansoprazoledexlansoprazoleTWI PHARMACEUTICALS, INC.NDA AUTHORIZED GENERICCurrent
24979-704DexlansoprazoledexlansoprazoleTWI PHARMACEUTICALS, INC.NDA AUTHORIZED GENERICCurrent
24979-704DexlansoprazoledexlansoprazoleTWI PHARMACEUTICALS, INC.NDA AUTHORIZED GENERICCurrent
50090-4374DexilantdexlansoprazoleA-S Medication SolutionsNDACurrent
50090-4374DexilantdexlansoprazoleA-S Medication SolutionsNDACurrent
50090-4374DexilantdexlansoprazoleA-S Medication SolutionsNDACurrent
50090-5944DexlansoprazoledexlansoprazoleA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5956DexlansoprazoledexlansoprazoleA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
55154-5154DexilantdexlansoprazoleCardinal HealthNDACurrent
55154-5154DexilantdexlansoprazoleCardinal HealthNDACurrent
55154-5154DexilantdexlansoprazoleCardinal HealthNDACurrent
55154-5154DexilantdexlansoprazoleCardinal HealthNDACurrent
55154-5154DexilantdexlansoprazoleCardinal Health 107, LLCNDACurrent
64764-171DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-171DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-171DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-171DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-171DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-171DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-171DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-175DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-175DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-175DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-175DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-175DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-175DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-175DexilantdexlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74822SUPPL 2023-07-20
74821SUPPL 2023-07-20
74781SUPPL 2023-07-19
73999SUPPL 2023-04-14
73987SUPPL 2023-04-14
70475SUPPL2022-03-10
70473SUPPL2022-03-10
70428SUPPL2022-03-07
65398SUPPL2020-11-30
65397SUPPL2020-11-30
65387SUPPL2020-11-30
64620SUPPL2020-09-21
64616SUPPL2020-09-21
54579SUPPL2018-06-14
54578SUPPL2018-06-14
54510SUPPL2018-06-11
54509SUPPL2018-06-11
54508SUPPL2018-06-11
54507SUPPL2018-06-11
50149SUPPL2017-10-23
50117SUPPL2017-10-19
45871SUPPL2016-11-10
45866SUPPL2016-11-10
38515SUPPL2016-07-20
38514SUPPL2016-07-20
17204SUPPL2016-07-20
29540SUPPL2016-07-12
29539SUPPL2016-07-12
7181SUPPL2016-07-12
38513SUPPL2016-02-11
29538SUPPL2016-02-04
7180SUPPL2015-12-18
38511SUPPL2015-12-17
38512SUPPL2014-12-29
29537SUPPL2014-12-23
29536SUPPL2013-08-22
38510SUPPL2013-08-21
29534SUPPL2012-10-02
38508SUPPL2012-10-01
29535SUPPL2012-05-09
38509SUPPL2012-05-07
23707ORIG2011-12-20
17202SUPPL2011-11-01
7179SUPPL2011-10-31
29532SUPPL2011-06-28
38507SUPPL2011-06-27
17203SUPPL2011-05-26
29533SUPPL2011-05-25
38506SUPPL2011-04-11
29531SUPPL2011-04-11
38505SUPPL2010-09-10
29530SUPPL2010-09-08
29528SUPPL2010-06-24
17199SUPPL2010-06-24
17201SUPPL2010-03-26
17200SUPPL2010-03-26
29529SUPPL2010-03-25
7178SUPPL2010-03-25
42479ORIG2009-06-24
24275ORIG2009-06-24
7177ORIG2009-02-04