FDA.reportPublic FDA data

Application 201281

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JENTADUETOLINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;500MGYesNo
002JENTADUETOLINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;850MGYesNo
003JENTADUETOLINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;1GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0146Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0146Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0146Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0146Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0147Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0147Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0147Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0147Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0148Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0148Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0148Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0148Jentaduetolinagliptin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
63629-6524Jentaduetolinagliptin and metformin hydrochlorideBryant Ranch PrepackNDACurrent
63629-6524Jentaduetolinagliptin and metformin hydrochlorideBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74600SUPPL 2023-06-22
74599SUPPL 2023-06-22
74573SUPPL 2023-06-21
70787SUPPL2022-04-18
70786SUPPL2022-04-18
70781SUPPL2022-04-18
62391SUPPL2020-03-31
62390SUPPL2020-03-31
62375SUPPL2020-03-31
59962SUPPL2019-09-10
59263SUPPL2019-07-08
59262SUPPL2019-07-08
59250SUPPL2019-07-05
59218SUPPL2019-07-02
49409SUPPL2017-08-15
49345SUPPL2017-08-11
47611SUPPL2017-03-21
47604SUPPL2017-03-20
46544SUPPL2016-12-27
46543SUPPL2016-12-27
46539SUPPL2016-12-27
46538SUPPL2016-12-27
40063SUPPL2015-09-03
32101SUPPL2015-09-01
19008SUPPL2015-07-30
32100SUPPL2015-07-29
32099SUPPL2014-07-31
19007SUPPL2014-07-31
40062SUPPL2014-05-28
9881SUPPL2014-05-23
32098SUPPL2013-09-10
19006SUPPL2013-09-09
24391ORIG2013-07-26
22849ORIG2013-07-26
40061SUPPL2013-06-25
32097SUPPL2013-06-20
9880SUPPL2012-09-27
32096ORIG2012-02-02
19005ORIG2012-02-01