FDA.reportPublic FDA data

Application 022000

Type
NDA
Sponsor
SHIRE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIALDAMESALAMINETABLET, DELAYED RELEASE;ORAL1.2GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0142LialdamesalamineKAISER FOUNDATION HOSPITANDACurrent
54092-100MesalamineMESALAMINETakeda Pharmaceuticals America, Inc.NDA AUTHORIZED GENERICCurrent
54092-100MesalamineMESALAMINETakeda Pharmaceuticals America, Inc.NDA AUTHORIZED GENERICCurrent
54092-100MesalamineMESALAMINEShire US Manufacturing Inc.NDA AUTHORIZED GENERICCurrent
54092-100MesalamineMESALAMINETakeda Pharmaceuticals America, Inc.NDA AUTHORIZED GENERICCurrent
54092-100MesalamineMESALAMINETakeda Pharmaceuticals America, Inc.NDA AUTHORIZED GENERICCurrent
54092-100MesalamineMESALAMINEShire US Manufacturing Inc.NDA AUTHORIZED GENERICCurrent
54092-476LialdamesalamineShire US Manufacturing Inc.NDACurrent
54092-476LialdamesalamineShire US Manufacturing Inc.NDACurrent
54092-476LialdamesalamineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-476LialdamesalamineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-476LialdamesalamineShire US Manufacturing Inc.NDACurrent
54092-476LialdamesalamineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-476LialdamesalamineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-476LialdamesalamineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-476LialdamesalamineTakeda Pharmaceuticals America, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75944SUPPL 2023-10-25
75929SUPPL 2023-10-25
72646SUPPL2022-11-17
72626SUPPL2022-11-17
69193SUPPL2021-11-02
69184SUPPL2021-11-02
67653SUPPL2021-06-02
67593SUPPL2021-05-26
65653SUPPL2020-12-21
65612SUPPL2020-12-17
64866SUPPL2020-10-07
64817SUPPL2020-10-05
63785SUPPL2020-07-02
63752SUPPL2020-06-30
59385SUPPL2019-07-19
59376SUPPL2019-07-19
54340SUPPL2018-05-25
54329SUPPL2018-05-24
49538SUPPL2017-08-25
49523SUPPL2017-08-24
49143SUPPL2017-07-31
49127SUPPL2017-07-28
42382SUPPL2015-03-09
29040SUPPL2014-10-21
16739SUPPL2014-10-21
29039SUPPL2013-12-17
16738SUPPL2013-12-17
16736SUPPL2013-09-24
6654SUPPL2013-08-29
38060SUPPL2013-08-12
29038SUPPL2013-08-12
16737SUPPL2013-08-12
6655SUPPL2013-08-12
38059SUPPL2011-07-18
6653SUPPL2011-07-18
29037SUPPL2010-09-27
16735SUPPL2010-09-23
38058SUPPL2009-12-10
42381ORIG2007-08-31
29036ORIG2007-01-25
16734ORIG2007-01-18