FDA.reportPublic FDA data

Application 209805

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STEGLUJANERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATETABLET;ORAL5MG;EQ 100MG BASEYesNo
002STEGLUJANERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATETABLET;ORAL15MG;EQ 100MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-5367STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5367STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5367STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5367STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-5367STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-5367STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5367STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5367STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5367STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5368STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5368STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5368STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5368STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-5368STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme LLCNDACurrent
0006-5368STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5368STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5368STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent
0006-5368STEGLUJANertugliflozin and sitagliptinMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80775SUPPL 2024-12-30
80774SUPPL 2024-12-30
80763SUPPL 2024-12-27
75432SUPPL 2023-09-13
75420SUPPL 2023-09-13
72366SUPPL2022-10-17
72365SUPPL2022-10-17
72335SUPPL2022-10-14
71436SUPPL2022-06-24
71435SUPPL2022-06-24
71423SUPPL2022-06-22
70393SUPPL2022-03-03
70392SUPPL2022-03-03
70383SUPPL2022-03-03
68689SUPPL2021-09-21
68664SUPPL2021-09-20
68663SUPPL2021-09-20
61677SUPPL2020-01-27
61657SUPPL2020-01-27
61656SUPPL2020-01-27
59322SUPPL2019-07-12
59321SUPPL2019-07-12
59206SUPPL2019-07-02
56186SUPPL2018-10-30
56152SUPPL2018-10-29
56151SUPPL2018-10-29
53001SUPPL2018-03-15
52857SUPPL2018-03-08
52856SUPPL2018-03-08
52809ORIG2018-03-05
50886ORIG2017-12-27
50791ORIG2017-12-20