FDA.reportPublic FDA data

Application 209806

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEGLUROMETERTUGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;500MGYesNo
002SEGLUROMETERTUGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;1GMYesNo
003SEGLUROMETERTUGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL7.5MG;500MGYesNo
004SEGLUROMETERTUGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET;ORAL7.5MG;1GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-5369SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5369SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-5369SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-5369SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5369SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5369SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5369SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5369SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5369SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5370SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-5370SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5370SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5370SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5370SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5370SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5370SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-5370SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5370SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5373SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5373SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5373SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5373SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5373SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5373SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5373SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-5373SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-5373SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5374SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5374SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5374SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-5374SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-5374SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5374SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5374SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5374SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-5374SEGLUROMETertugliflozin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
50090-6217SEGLUROMETertugliflozin and metformin hydrochlorideA-S Medication SolutionsNDACurrent
50090-6218SEGLUROMETertugliflozin and metformin hydrochlorideA-S Medication SolutionsNDACurrent
50090-6231SEGLUROMETertugliflozin and metformin hydrochlorideA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80777SUPPL 2024-12-30
80776SUPPL 2024-12-30
80764SUPPL 2024-12-27
75430SUPPL 2023-09-13
75421SUPPL 2023-09-13
72364SUPPL2022-10-17
72363SUPPL2022-10-17
72336SUPPL2022-10-14
70391SUPPL2022-03-03
70390SUPPL2022-03-03
70384SUPPL2022-03-03
68690SUPPL2021-09-21
68666SUPPL2021-09-20
68665SUPPL2021-09-20
61678SUPPL2020-01-27
61659SUPPL2020-01-27
61658SUPPL2020-01-27
56187SUPPL2018-10-30
56154SUPPL2018-10-29
56153SUPPL2018-10-29
52810ORIG2018-03-05
50887ORIG2017-12-27
50793ORIG2017-12-19