FDA.reportPublic FDA data

Application 020123

Type
NDA
Sponsor
GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMNISCANGADODIAMIDEINJECTABLE;INJECTION287MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0407-0690OMNISCANgadodiamideGE Healthcare Inc.NDACurrent
0407-0690OMNISCANgadodiamideGE Healthcare Inc.NDACurrent
0407-0690OMNISCANgadodiamideGE Healthcare Inc.NDACurrent
0407-0690OMNISCANgadodiamideGE Healthcare Inc.NDACurrent
0407-0690OMNISCANgadodiamideGE Healthcare Inc.NDACurrent
0407-0690OMNISCANgadodiamideGE Healthcare Inc.NDACurrent
0407-0691OMNISCANgadodiamideGE Healthcare Inc.NDACurrent
0407-0691OMNISCANgadodiamideGE Healthcare Inc.NDACurrent
0407-0691OMNISCANgadodiamideGE Healthcare Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81483SUPPL 2025-03-07
81482SUPPL 2025-03-07
81446SUPPL 2025-03-06
79422SUPPL 2024-08-16
79199SUPPL 2024-07-24
79174SUPPL 2024-07-24
77352SUPPL 2024-01-29
77326SUPPL 2024-01-29
56333SUPPL2018-11-08
56303SUPPL2018-11-06
53892SUPPL2018-05-01
53861SUPPL2018-04-27
53860SUPPL2018-04-27
34278SUPPL2014-11-20
2041SUPPL2014-11-18
2040SUPPL2013-08-29
12233SUPPL2013-08-28
2039SUPPL2010-12-22
12232SUPPL2010-12-20
21185SUPPL2008-01-09
12231SUPPL2007-12-27
21184SUPPL2007-09-07
34277SUPPL2007-09-06
23567ORIG2006-06-09
21183SUPPL2003-07-31
2038SUPPL2002-07-08
21182SUPPL2002-06-28
21181SUPPL2002-05-17
20477SUPPL1997-10-03