FDA.reportPublic FDA data

Application 208658

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYNJARDY XREMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1GMYesNo
002SYNJARDY XREMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;1GMYesNo
003SYNJARDY XREMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL12.5MG;1GMYesNo
004SYNJARDY XREMPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL25MG;1GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0280Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0280Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0280Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0280Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0280Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0290Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0290Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0290Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0290Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0290Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0295Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0295Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0295Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0295Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0295Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0300Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0300Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0300Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0300Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0300Synjardyempagliflozin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83953SUPPL 2025-10-28
83929SUPPL 2025-10-27
83928SUPPL 2025-10-27
81528SUPPL 2025-03-11
81511SUPPL 2025-03-11
76013SUPPL 2023-10-31
76001SUPPL 2023-10-31
74597SUPPL 2023-06-22
74596SUPPL 2023-06-22
74578SUPPL 2023-06-21
74577SUPPL 2023-06-21
73454SUPPL 2023-02-10
73397SUPPL 2023-02-07
72374SUPPL2022-10-17
72373SUPPL2022-10-17
72340SUPPL2022-10-14
70625SUPPL2022-03-28
70624SUPPL2022-03-28
70583SUPPL2022-03-22
67793SUPPL2021-06-14
67792SUPPL2021-06-14
67791SUPPL2021-06-14
67790SUPPL2021-06-14
67789SUPPL2021-06-14
61675SUPPL2020-01-27
61668SUPPL2020-01-27
61667SUPPL2020-01-27
56178SUPPL2018-10-30
56164SUPPL2018-10-29
56163SUPPL2018-10-29
50714SUPPL2017-12-15
50690SUPPL2017-12-14
50689SUPPL2017-12-14
50199ORIG2017-10-26
46555SUPPL2016-12-27
46542SUPPL2016-12-27
46166ORIG2016-12-15
46128ORIG2016-12-13