FDA.reportPublic FDA data

Application 020351

Type
NDA
Sponsor
GE HEALTHCARE

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0407-2222VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2222VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2222VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2222VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2222VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2223VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2223VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2223VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2223VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2223VisipaqueIodixanolGE Healthcare Inc.NDACurrent
0407-2223VisipaqueIodixanolGE Healthcare Inc.NDACurrent
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
74085SUPPL 2023-04-27
74079SUPPL 2023-04-27
70251SUPPL2022-02-24
70214SUPPL2022-02-22
63802SUPPL2020-07-06
63797SUPPL2020-07-06
62885SUPPL2020-05-11
58917SUPPL2019-06-03
57990SUPPL2019-03-14
57981SUPPL2019-03-13
47958SUPPL2017-04-12
47944SUPPL2017-04-12
47899SUPPL2017-04-07
47894SUPPL2017-04-07
2362SUPPL2015-07-10
34528SUPPL2015-07-09
24806SUPPL2005-08-31
24805SUPPL2005-04-28
24804SUPPL2005-01-11
2360SUPPL2004-06-30
24803SUPPL2004-03-28
34527SUPPL2003-12-29
2361SUPPL2003-12-23
24802SUPPL2003-09-25
51199SUPPL1900-01-01
51198SUPPL1900-01-01
51196SUPPL1900-01-01
51195SUPPL1900-01-01