FDA.reportPublic FDA data

Application 212097

Type
NDA
Sponsor
XERIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GVOKE PFSGLUCAGONSOLUTION;SUBCUTANEOUS0.5MG/0.1ML (0.5MG/0.1ML)YesYes
002GVOKE PFSGLUCAGONSOLUTION;SUBCUTANEOUS1MG/0.2ML (1MG/0.2ML)YesYes
003GVOKE HYPOPENGLUCAGONSOLUTION;SUBCUTANEOUS0.5MG/0.1ML (0.5MG/0.1ML)YesYes
004GVOKE HYPOPENGLUCAGONSOLUTION;SUBCUTANEOUS1MG/0.2ML (1MG/0.2ML)YesYes
005GVOKE KITGLUCAGONSOLUTION;SUBCUTANEOUS0.5MG/0.1ML (0.5MG/0.1ML)NoNo
006GVOKE KITGLUCAGONSOLUTION;SUBCUTANEOUS1MG/0.2ML (1MG/0.2ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72065-120Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-120Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-120Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-120Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-120Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-120Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-120Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-120Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-120Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-120Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-120Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-121Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-121Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-121Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-121Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-121Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-121Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-121Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-121Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-121Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-121Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-121Gvoke HypoPenglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-130Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-130Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-130Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-130Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-130Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-130Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-130Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-130Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-130Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-130Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-130Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-131Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-131Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-131Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-131Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-131Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-131Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-131Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-131Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-131Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-131Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-131Gvoke PFSglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-140Gvoke Kitglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-140Gvoke Kitglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-141Gvoke Kitglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent
72065-141Gvoke Kitglucagon injection, solutionXeris Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81641SUPPL 2025-03-18
81621SUPPL 2025-03-18
77174SUPPL 2024-01-02
77140SUPPL 2023-12-27
68449SUPPL2021-08-24
68440SUPPL2021-08-22
68138SUPPL2021-07-20
68112SUPPL2021-07-19
62470SUPPL2020-04-08
61943ORIG2020-02-21
59952ORIG2019-12-18
59970ORIG2019-09-11
63059ORIG1900-01-01
63058ORIG1900-01-01
63057ORIG1900-01-01
63056ORIG1900-01-01