FDA.reportPublic FDA data

Application 020608

Type
NDA
Sponsor
GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMNIPAQUE 240IOHEXOLSOLUTION;INJECTION, ORAL, RECTAL51.8%NoNo
002OMNIPAQUE 300IOHEXOLSOLUTION;INJECTION, ORAL, RECTAL64.7%NoNo
003OMNIPAQUE 350IOHEXOLSOLUTION;INJECTION, ORAL75.5%NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020608-001OMNIPAQUE 240IOHEXOL51.8%SOLUTION / INJECTION, ORAL, RECTAL1995-10-24
N020608-002OMNIPAQUE 300IOHEXOL64.7%SOLUTION / INJECTION, ORAL, RECTAL1995-10-24
N020608-003OMNIPAQUE 350IOHEXOL75.5%SOLUTION / INJECTION, ORAL1995-10-24

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020608-001OMNIPAQUE 24051.8%SOLUTION / INJECTION, ORAL, RECTAL1995-10-24f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020608-002OMNIPAQUE 30064.7%SOLUTION / INJECTION, ORAL, RECTAL1995-10-24f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020608-003OMNIPAQUE 35075.5%SOLUTION / INJECTION, ORAL1995-10-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020608-001OMNIPAQUE 24051.8%SOLUTION / INJECTION, ORAL, RECTAL1995-10-24e64feba35796…
2022-09-29 23:25 UTC2022-09N020608-002OMNIPAQUE 30064.7%SOLUTION / INJECTION, ORAL, RECTAL1995-10-24e64feba35796…
2022-09-29 23:25 UTC2022-09N020608-003OMNIPAQUE 35075.5%SOLUTION / INJECTION, ORAL1995-10-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020608-001OMNIPAQUE 24051.8%SOLUTION / INJECTION, ORAL, RECTAL1995-10-24cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020608-002OMNIPAQUE 30064.7%SOLUTION / INJECTION, ORAL, RECTAL1995-10-24cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020608-003OMNIPAQUE 35075.5%SOLUTION / INJECTION, ORAL1995-10-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020608-001OMNIPAQUE 24051.8%SOLUTION / INJECTION, ORAL, RECTAL1995-10-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020608-002OMNIPAQUE 30064.7%SOLUTION / INJECTION, ORAL, RECTAL1995-10-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020608-003OMNIPAQUE 35075.5%SOLUTION / INJECTION, ORAL1995-10-24a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OMNIPAQUEIOHEXOLGE Healthcare Inc.eee15ebe-d349-4497-acef-6abe7a8247fb2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 0407-1414
ndc (product): 0407-1413
OmnipaqueIOHEXOLGE Healthcare164b27b9-97ae-4279-896f-1c4afa583dd12026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020608
application number: NDA020608
ndc (product): 0407-1414
ndc (product): 0407-1413

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 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0407-1413OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1413OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1413OmnipaqueIohexolGE HealthcareNDACurrent
0407-1413OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1413OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1413OmnipaqueIohexolGE HealthcareNDACurrent
0407-1413OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1413OmnipaqueIohexolGE HealthcareNDACurrent
0407-1413OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1413OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1413OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1413OmnipaqueIohexolGE HealthcareNDACurrent
0407-1413OmnipaqueIohexolGE HealthcareNDACurrent
0407-1413OmnipaqueIohexolGE HealthcareNDACurrent
0407-1413OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1413OmnipaqueIohexolGE HealthcareNDACurrent
0407-1413OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1413OmnipaqueIohexolGE HealthcareNDACurrent
0407-1414OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1414OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1414OmnipaqueIohexolGE HealthcareNDACurrent
0407-1414OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1414OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1414OmnipaqueIohexolGE HealthcareNDACurrent
0407-1414OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1414OmnipaqueIohexolGE HealthcareNDACurrent
0407-1414OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1414OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1414OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1414OmnipaqueIohexolGE HealthcareNDACurrent
0407-1414OmnipaqueIohexolGE HealthcareNDACurrent
0407-1414OmnipaqueIohexolGE HealthcareNDACurrent
0407-1414OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1414OmnipaqueIohexolGE HealthcareNDACurrent
0407-1414OmnipaqueIohexolGE Healthcare Inc.NDACurrent
0407-1414OmnipaqueIohexolGE HealthcareNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79848SUPPL 2024-10-09
79843SUPPL 2024-10-09
74083SUPPL 2023-04-27
74074SUPPL 2023-04-27
70269SUPPL2022-02-25
70220SUPPL2022-02-22
50403SUPPL2017-11-14
50384SUPPL2017-11-13
47965SUPPL2017-04-12
47898SUPPL2017-04-07
47897SUPPL2017-04-07
46523SUPPL2016-12-23
46498SUPPL2016-12-21
25319SUPPL2015-07-10
12842SUPPL2015-07-09
2869SUPPL2007-10-04
25317SUPPL2004-03-10
25318SUPPL2004-03-03