Application 020808

Type
NDA
Sponsor
GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VISIPAQUE 270IODIXANOLINJECTABLE;INJECTION55%NoNo
002VISIPAQUE 320IODIXANOLINJECTABLE;INJECTION65.2%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0407-2223VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2223VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2223VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2223VisipaqueIodixanolGE Healthcare Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74086SUPPL 2023-04-27
74080SUPPL 2023-04-27
70252SUPPL2022-02-24
58920SUPPL2019-06-03
57992SUPPL2019-03-14
57980SUPPL2019-03-13
47957SUPPL2017-04-12
47943SUPPL2017-04-12
47900SUPPL2017-04-07
47895SUPPL2017-04-07
3399SUPPL2015-07-10
35390SUPPL2015-07-09
41715SUPPL2004-06-30
35389SUPPL2003-12-29
25880SUPPL2003-12-23
25879SUPPL2003-09-25