Application 020608

Type: NDA
Sponsor: GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMNIPAQUE 240	IOHEXOL	SOLUTION;INJECTION, ORAL, RECTAL	51.8%	No	No
002	OMNIPAQUE 300	IOHEXOL	SOLUTION;INJECTION, ORAL, RECTAL	64.7%	No	No
003	OMNIPAQUE 350	IOHEXOL	SOLUTION;INJECTION, ORAL	75.5%	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N020608-001	OMNIPAQUE 240	IOHEXOL	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24
N020608-002	OMNIPAQUE 300	IOHEXOL	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24
N020608-003	OMNIPAQUE 350	IOHEXOL	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020608-003	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	1995-10-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020608-001	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020608-002	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	1995-10-24	`c0c555d07b60…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OMNIPAQUE	IOHEXOL	GE Healthcare Inc.	eee15ebe-d349-4497-acef-6abe7a8247fb	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0407-1414 ndc (product): 0407-1413
Omnipaque	IOHEXOL	GE Healthcare	164b27b9-97ae-4279-896f-1c4afa583dd1	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact 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
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0407-1413	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	Omnipaque	Iohexol	GE Healthcare	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79848	SUPPL	2024-10-09
79843	SUPPL	2024-10-09
74083	SUPPL	2023-04-27
74074	SUPPL	2023-04-27
70269	SUPPL	2022-02-25
70220	SUPPL	2022-02-22
50403	SUPPL	2017-11-14
50384	SUPPL	2017-11-13
47965	SUPPL	2017-04-12
47898	SUPPL	2017-04-07
47897	SUPPL	2017-04-07
46523	SUPPL	2016-12-23
46498	SUPPL	2016-12-21
25319	SUPPL	2015-07-10
12842	SUPPL	2015-07-09
2869	SUPPL	2007-10-04
25317	SUPPL	2004-03-10
25318	SUPPL	2004-03-03