Application 020808

Type: NDA
Sponsor: GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VISIPAQUE 270	IODIXANOL	INJECTABLE;INJECTION	55%	No	No
002	VISIPAQUE 320	IODIXANOL	INJECTABLE;INJECTION	65.2%	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020808-001	VISIPAQUE 270	IODIXANOL	55%	INJECTABLE / INJECTION			1997-08-29
N020808-002	VISIPAQUE 320	IODIXANOL	65.2%	INJECTABLE / INJECTION			1997-08-29

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020808-001	VISIPAQUE 270	55%	INJECTABLE / INJECTION	1997-08-29	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020808-002	VISIPAQUE 320	65.2%	INJECTABLE / INJECTION	1997-08-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020808-001	VISIPAQUE 270	55%	INJECTABLE / INJECTION	1997-08-29	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020808-002	VISIPAQUE 320	65.2%	INJECTABLE / INJECTION	1997-08-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020808-001	VISIPAQUE 270	55%	INJECTABLE / INJECTION	1997-08-29	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020808-002	VISIPAQUE 320	65.2%	INJECTABLE / INJECTION	1997-08-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020808-001	VISIPAQUE 270	55%	INJECTABLE / INJECTION	1997-08-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020808-002	VISIPAQUE 320	65.2%	INJECTABLE / INJECTION	1997-08-29	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020808-002	I-752	2020-04-05	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020808-002	I-752	2020-04-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020808-002	I-752	2020-04-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020808-002	I-752	2020-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020808-002	I-752	2020-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020808-002	I-752	2020-04-05	`ea99ee380514…`

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
Visipaque	IODIXANOL	GE Healthcare Inc.	2d964c13-88ad-43be-88d4-a3a7ea4d5b5e	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020808 application number: NDA020808 ndc (product): 0407-2223
Visipaque	IODIXANOL	GE Healthcare Inc.	e9d87b8c-7695-4c0f-8e81-000dedb5f66d	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0407-2223

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0407-2223	Visipaque	Iodixanol	GE Healthcare Inc.	NDA	Current
0407-2223	Visipaque	Iodixanol	GE Healthcare Inc.	NDA	Current
0407-2223	Visipaque	Iodixanol	GE Healthcare Inc.	NDA	Current
0407-2223	Visipaque	Iodixanol	GE Healthcare Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74086	SUPPL	2023-04-27
74080	SUPPL	2023-04-27
70252	SUPPL	2022-02-24
58920	SUPPL	2019-06-03
57992	SUPPL	2019-03-14
57980	SUPPL	2019-03-13
47957	SUPPL	2017-04-12
47943	SUPPL	2017-04-12
47900	SUPPL	2017-04-07
47895	SUPPL	2017-04-07
3399	SUPPL	2015-07-10
35390	SUPPL	2015-07-09
41715	SUPPL	2004-06-30
35389	SUPPL	2003-12-29
25880	SUPPL	2003-12-23
25879	SUPPL	2003-09-25