FDA.reportPublic FDA data

Application 209803

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STEGLATROERTUGLIFLOZINTABLET;ORAL5MGYesNo
002STEGLATROERTUGLIFLOZINTABLET;ORAL15MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-5363STEGLATROertugliflozinMerck Sharp & Dohme LLCNDACurrent
0006-5363STEGLATROertugliflozinMerck Sharp & Dohme LLCNDACurrent
0006-5363STEGLATROertugliflozinMerck Sharp & Dohme Corp.NDACurrent
0006-5363STEGLATROertugliflozinMerck Sharp & Dohme Corp.NDACurrent
0006-5363STEGLATROertugliflozinMerck Sharp & Dohme Corp.NDACurrent
0006-5363STEGLATROertugliflozinMerck Sharp & Dohme Corp.NDACurrent
0006-5363STEGLATROertugliflozinMerck Sharp & Dohme Corp.NDACurrent
0006-5364STEGLATROertugliflozinMerck Sharp & Dohme LLCNDACurrent
0006-5364STEGLATROertugliflozinMerck Sharp & Dohme LLCNDACurrent
0006-5364STEGLATROertugliflozinMerck Sharp & Dohme Corp.NDACurrent
0006-5364STEGLATROertugliflozinMerck Sharp & Dohme Corp.NDACurrent
0006-5364STEGLATROertugliflozinMerck Sharp & Dohme Corp.NDACurrent
0006-5364STEGLATROertugliflozinMerck Sharp & Dohme Corp.NDACurrent
0006-5364STEGLATROertugliflozinMerck Sharp & Dohme Corp.NDACurrent
50090-6182STEGLATROertugliflozinA-S Medication SolutionsNDACurrent
50090-6183STEGLATROertugliflozinA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80773SUPPL 2024-12-30
80772SUPPL 2024-12-30
80762SUPPL 2024-12-27
75434SUPPL 2023-09-13
75419SUPPL 2023-09-13
72368SUPPL2022-10-17
72367SUPPL2022-10-17
72334SUPPL2022-10-14
68688SUPPL2021-09-21
68662SUPPL2021-09-20
68661SUPPL2021-09-20
61676SUPPL2020-01-27
61669SUPPL2020-01-27
61655SUPPL2020-01-27
56185SUPPL2018-10-30
56156SUPPL2018-10-29
56155SUPPL2018-10-29
52808ORIG2018-03-05
50885ORIG2017-12-27
50797ORIG2017-12-20
50796ORIG2017-12-20