FDA.reportPublic FDA data

Application 210166

Type
NDA
Sponsor
SHIRE DEV LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOTEGRITYPRUCALOPRIDE SUCCINATETABLET;ORALEQ 1MG BASEYesNo
002MOTEGRITYPRUCALOPRIDE SUCCINATETABLET;ORALEQ 2MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54092-546MOTEGRITYPRUCALOPRIDETakeda Pharmaceuticals America, Inc.NDACurrent
54092-546MOTEGRITYPRUCALOPRIDETakeda Pharmaceuticals America, Inc.NDACurrent
54092-546MOTEGRITYPRUCALOPRIDEShire US Manufacturing Inc.NDACurrent
54092-546MOTEGRITYPRUCALOPRIDETakeda Pharmaceuticals America, Inc.NDACurrent
54092-546MOTEGRITYPRUCALOPRIDETakeda Pharmaceuticals America, Inc.NDACurrent
54092-546MOTEGRITYPRUCALOPRIDETakeda Pharmaceuticals America, Inc.NDACurrent
54092-546MOTEGRITYPRUCALOPRIDEShire US Manufacturing Inc.NDACurrent
54092-547MOTEGRITYPRUCALOPRIDETakeda Pharmaceuticals America, Inc.NDACurrent
54092-547MOTEGRITYPRUCALOPRIDETakeda Pharmaceuticals America, Inc.NDACurrent
54092-547MOTEGRITYPRUCALOPRIDEShire US Manufacturing Inc.NDACurrent
54092-547MOTEGRITYPRUCALOPRIDETakeda Pharmaceuticals America, Inc.NDACurrent
54092-547MOTEGRITYPRUCALOPRIDETakeda Pharmaceuticals America, Inc.NDACurrent
54092-547MOTEGRITYPRUCALOPRIDETakeda Pharmaceuticals America, Inc.NDACurrent
54092-547MOTEGRITYPRUCALOPRIDEShire US Manufacturing Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82816SUPPL 2025-07-11
82786SUPPL 2025-07-11
65195SUPPL2020-11-12
65181SUPPL2020-11-10
57043ORIG2018-12-28
56890ORIG2018-12-20
56744ORIG2018-12-14