FDA.reportPublic FDA data

Application 208026

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JENTADUETO XRLINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL2.5MG;1GMYesNo
002JENTADUETO XRLINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0270Jentadueto XRlinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0270Jentadueto XRlinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0270Jentadueto XRlinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0270Jentadueto XRlinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0275Jentadueto XRlinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0275Jentadueto XRlinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0275Jentadueto XRlinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0275Jentadueto XRlinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74602SUPPL 2023-06-22
74601SUPPL 2023-06-22
74574SUPPL 2023-06-21
68875SUPPL2021-10-05
68855SUPPL2021-10-01
68854SUPPL2021-10-01
62387SUPPL2020-03-31
62386SUPPL2020-03-31
62377SUPPL2020-03-31
59965SUPPL2019-09-10
59259SUPPL2019-07-08
59258SUPPL2019-07-08
59252SUPPL2019-07-05
59221SUPPL2019-07-02
49410SUPPL2017-08-15
49343SUPPL2017-08-11
48819ORIG2017-06-23
48818ORIG2017-06-23
47616SUPPL2017-03-21
47606SUPPL2017-03-20
46554SUPPL2016-12-27
46541SUPPL2016-12-27
40612ORIG2016-06-01
32878ORIG2016-06-01