FDA.reportPublic FDA data

Application 206073

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYXAMBIEMPAGLIFLOZIN; LINAGLIPTINTABLET;ORAL10MG;5MGYesNo
002GLYXAMBIEMPAGLIFLOZIN; LINAGLIPTINTABLET;ORAL25MG;5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0164Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0164Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0164Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0164Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0164Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0164Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0164Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0164Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0182Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0182Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0182Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0182Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0182Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0182Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0182Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0182Glyxambiempagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
70518-2046Glyxambiempagliflozin and linagliptinREMEDYREPACK INC.NDACurrent
70518-2046Glyxambiempagliflozin and linagliptinREMEDYREPACK INC.NDACurrent
70518-2046Glyxambiempagliflozin and linagliptinREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83954SUPPL 2025-10-28
83931SUPPL 2025-10-27
83930SUPPL 2025-10-27
76011SUPPL 2023-10-31
75997SUPPL 2023-10-31
72378SUPPL2022-10-17
72377SUPPL2022-10-17
72338SUPPL2022-10-14
70627SUPPL2022-03-28
70626SUPPL2022-03-28
70581SUPPL2022-03-22
68766SUPPL2021-09-24
68765SUPPL2021-09-24
67802SUPPL2021-06-15
67801SUPPL2021-06-15
67788SUPPL2021-06-14
67787SUPPL2021-06-14
67786SUPPL2021-06-14
62389SUPPL2020-03-31
62388SUPPL2020-03-31
62376SUPPL2020-03-31
61673SUPPL2020-01-27
61666SUPPL2020-01-27
61665SUPPL2020-01-27
59964SUPPL2019-09-10
59261SUPPL2019-07-08
59260SUPPL2019-07-08
59251SUPPL2019-07-05
59220SUPPL2019-07-02
56176SUPPL2018-10-30
56160SUPPL2018-10-29
56159SUPPL2018-10-29
50716SUPPL2017-12-15
50694SUPPL2017-12-14
50693SUPPL2017-12-14
49415SUPPL2017-08-15
49411SUPPL2017-08-15
49355SUPPL2017-08-14
49341SUPPL2017-08-11
47613SUPPL2017-03-21
47605SUPPL2017-03-20
46641SUPPL2017-01-03
46640SUPPL2017-01-03
46557SUPPL2016-12-27
46556SUPPL2016-12-27
10544SUPPL2016-07-11
44937ORIG2016-04-11
43509ORIG2016-04-11
19703SUPPL2015-12-08
10543SUPPL2015-12-07
19702SUPPL2015-09-04
32777SUPPL2015-09-01
40523ORIG2015-02-03
32776ORIG2015-02-03