FDA.reportPublic FDA data

Application 206111

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL5MG;500MGYesNo
002SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL5MG;1GMYesNo
003SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL12.5MG;500MGYesNo
004SYNJARDYEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL12.5MG;1GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0159Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0159Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0159Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0159Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0159Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0168Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0168Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0168Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0168Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0168Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0175Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0175Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0175Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0175Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0175Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0180Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0180Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0180Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0180Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0180Synjardyempagliflozin and metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83952SUPPL 2025-10-28
83927SUPPL 2025-10-27
83925SUPPL 2025-10-27
81526SUPPL 2025-03-11
81510SUPPL 2025-03-11
76012SUPPL 2023-10-31
75999SUPPL 2023-10-31
74593SUPPL 2023-06-22
74590SUPPL 2023-06-22
74576SUPPL 2023-06-21
73453SUPPL 2023-02-10
73396SUPPL 2023-02-07
72376SUPPL2022-10-17
72375SUPPL2022-10-17
72339SUPPL2022-10-14
70633SUPPL2022-03-28
70632SUPPL2022-03-28
70582SUPPL2022-03-22
67804SUPPL2021-06-15
67803SUPPL2021-06-15
67796SUPPL2021-06-14
67795SUPPL2021-06-14
67794SUPPL2021-06-14
61674SUPPL2020-01-27
61662SUPPL2020-01-27
56177SUPPL2018-10-30
56162SUPPL2018-10-29
56161SUPPL2018-10-29
50713SUPPL2017-12-15
50691SUPPL2017-12-14
50688SUPPL2017-12-14
46665SUPPL2017-01-04
46664SUPPL2017-01-04
46663SUPPL2017-01-04
46558SUPPL2016-12-27
46545SUPPL2016-12-27
45357SUPPL2016-09-22
45356SUPPL2016-09-22
46077ORIG2016-08-04
32780SUPPL2016-07-12
40525SUPPL2015-12-08
32781SUPPL2015-12-07
40524ORIG2015-09-02
32779ORIG2015-09-02