FDA.reportPublic FDA data

Application 022090

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EOVISTGADOXETATE DISODIUMSOLUTION;INTRAVENOUS1.8143GM/10ML (181.43MG/ML)YesYes
002EOVISTGADOXETATE DISODIUMSOLUTION;INTRAVENOUS2.72145GM/15ML (181.43MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-320EOVISTGadoxetate DisodiumBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-320EOVISTGadoxetate DisodiumBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-320EOVISTGadoxetate DisodiumBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-320EOVISTGadoxetate DisodiumBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-320EOVISTGadoxetate DisodiumBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-320EOVISTGadoxetate DisodiumBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-320EOVISTGadoxetate DisodiumBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-320EOVISTGadoxetate DisodiumBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85097SUPPL 2026-02-20
85096SUPPL 2026-02-20
85049SUPPL 2026-02-18
81490SUPPL 2025-03-07
81452SUPPL 2025-03-06
79417SUPPL 2024-08-16
79195SUPPL 2024-07-24
79178SUPPL 2024-07-24
77358SUPPL 2024-01-31
77356SUPPL 2024-01-31
69817SUPPL2022-01-06
69798SUPPL2021-12-29
69795SUPPL2021-12-29
69453SUPPL2021-12-02
69452SUPPL2021-12-02
56455SUPPL2018-11-15
56306SUPPL2018-11-06
55037SUPPL2018-07-30
55024SUPPL2018-07-27
55021SUPPL2018-07-27
53907SUPPL2018-05-01
53856SUPPL2018-04-27
38220SUPPL2015-04-01
6866SUPPL2015-04-01
38219SUPPL2013-10-18
6865SUPPL2013-10-18
23697ORIG2011-12-21
38218SUPPL2011-11-21
6864SUPPL2011-11-21
6863SUPPL2010-12-22
38217SUPPL2010-12-20
29229SUPPL2009-11-19
42412ORIG2008-08-19
24240ORIG2008-08-19
6862ORIG2008-07-15
38216ORIG2008-07-09
51148ORIG1900-01-01
51147ORIG1900-01-01