FDA.reportPublic FDA data

Application 020123

Type
NDA
Sponsor
GE HEALTHCARE

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020123-001OMNISCANGADODIAMIDE287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OMNISCANGADODIAMIDEGE Healthcare Inc.1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a2025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020123
application number: NDA020123
ndc (product): 0407-0690

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

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