FDA.reportPublic FDA data

Application 212614

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIJARDY XREMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;2.5MG;1GMYesNo
002TRIJARDY XREMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;5MG;1GMYesNo
003TRIJARDY XREMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL12.5MG;2.5MG;1GMYesNo
004TRIJARDY XREMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL25MG;5MG;1GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0380Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0380Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0380Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0380Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0385Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0385Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0385Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0385Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0390Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0390Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0390Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0390Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0395Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0395Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0395Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0395Trijardy XRempagliflozin, linagliptin, metformin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83955SUPPL 2025-10-28
83935SUPPL 2025-10-27
83934SUPPL 2025-10-27
76014SUPPL 2023-10-31
76003SUPPL 2023-10-31
72486SUPPL2022-10-28
72485SUPPL2022-10-28
72326SUPPL2022-10-14
67806SUPPL2021-06-15
67805SUPPL2021-06-15
67785SUPPL2021-06-14
67784SUPPL2021-06-14
67783SUPPL2021-06-14
65143SUPPL2020-11-03
65142SUPPL2020-11-03
65133SUPPL2020-11-03
64830ORIG2020-10-05
61705ORIG2020-01-28
61703ORIG2020-01-28
61702ORIG2020-01-28