FDA.reportPublic FDA data

Application 201280

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRADJENTALINAGLIPTINTABLET;ORAL5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0140TradjentalinagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0140TradjentalinagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0140TradjentalinagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0140TradjentalinagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0140TradjentalinagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
50090-4383TradjentalinagliptinA-S Medication SolutionsNDACurrent
50090-4383TradjentalinagliptinA-S Medication SolutionsNDACurrent
55154-0410TradjentalinagliptinCardinal Health 107, LLCNDACurrent
55154-0410TradjentalinagliptinCardinal HealthNDACurrent
55154-0410TradjentalinagliptinCardinal HealthNDACurrent
55154-0410TradjentalinagliptinCardinal HealthNDACurrent
55154-0410TradjentalinagliptinCardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74595SUPPL 2023-06-22
74594SUPPL 2023-06-22
74572SUPPL 2023-06-21
70784SUPPL2022-04-18
70783SUPPL2022-04-18
70780SUPPL2022-04-18
62393SUPPL2020-03-31
62392SUPPL2020-03-31
62374SUPPL2020-03-31
59963SUPPL2019-09-10
59265SUPPL2019-07-08
59264SUPPL2019-07-08
59249SUPPL2019-07-05
59217SUPPL2019-07-02
49408SUPPL2017-08-15
49347SUPPL2017-08-11
47609SUPPL2017-03-21
47603SUPPL2017-03-20
46618SUPPL2016-12-30
46553SUPPL2016-12-27
40060SUPPL2015-09-04
9879SUPPL2015-09-01
19004SUPPL2015-07-30
32095SUPPL2015-07-29
43362SUPPL2014-07-07
40059SUPPL2014-05-28
9878SUPPL2014-05-23
19003SUPPL2013-06-25
9877SUPPL2013-06-20
9876SUPPL2012-10-02
19002SUPPL2012-10-01
40058SUPPL2012-08-15
32094SUPPL2012-08-15
19001SUPPL2012-08-15
9875SUPPL2012-08-15
32093SUPPL2012-05-24
19000SUPPL2012-05-23
43361ORIG2011-06-07
24390ORIG2011-06-07
32092ORIG2011-05-06
18999ORIG2011-05-06