Application 022090

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EOVIST	GADOXETATE DISODIUM	SOLUTION;INTRAVENOUS	1.8143GM/10ML (181.43MG/ML)	Yes	Yes
002	EOVIST	GADOXETATE DISODIUM	SOLUTION;INTRAVENOUS	2.72145GM/15ML (181.43MG/ML)	Yes	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
N022090-001	EOVIST	GADOXETATE DISODIUM	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-07-03
N022090-002	EOVIST	GADOXETATE DISODIUM	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-02-04

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022090-001	EOVIST	1.8143GM/10ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2008-07-03	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022090-002	EOVIST	2.72145GM/15ML (181.43MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-02-04	`3a93d1ddd44b…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022090-001	6039931	2021-11-13	U-1239	2012-05-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022090-002	6039931	2021-11-13	U-1239	2018-06-05	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EOVIST	GADOXETATE DISODIUM	Bayer HealthCare Pharmaceuticals Inc.	6218b1e1-cbc3-4c14-bec7-528ac163a561	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022090 application number: NDA022090 ndc (product): 50419-320

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-320	EOVIST	Gadoxetate Disodium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-320	EOVIST	Gadoxetate Disodium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-320	EOVIST	Gadoxetate Disodium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-320	EOVIST	Gadoxetate Disodium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-320	EOVIST	Gadoxetate Disodium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-320	EOVIST	Gadoxetate Disodium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-320	EOVIST	Gadoxetate Disodium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-320	EOVIST	Gadoxetate Disodium	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85097	SUPPL	2026-02-20
85096	SUPPL	2026-02-20
85049	SUPPL	2026-02-18
81490	SUPPL	2025-03-07
81452	SUPPL	2025-03-06
79417	SUPPL	2024-08-16
79195	SUPPL	2024-07-24
79178	SUPPL	2024-07-24
77358	SUPPL	2024-01-31
77356	SUPPL	2024-01-31
69817	SUPPL	2022-01-06
69798	SUPPL	2021-12-29
69795	SUPPL	2021-12-29
69453	SUPPL	2021-12-02
69452	SUPPL	2021-12-02
56455	SUPPL	2018-11-15
56306	SUPPL	2018-11-06
55037	SUPPL	2018-07-30
55024	SUPPL	2018-07-27
55021	SUPPL	2018-07-27
53907	SUPPL	2018-05-01
53856	SUPPL	2018-04-27
38220	SUPPL	2015-04-01
6866	SUPPL	2015-04-01
38219	SUPPL	2013-10-18
6865	SUPPL	2013-10-18
23697	ORIG	2011-12-21
38218	SUPPL	2011-11-21
6864	SUPPL	2011-11-21
6863	SUPPL	2010-12-22
38217	SUPPL	2010-12-20
29229	SUPPL	2009-11-19
42412	ORIG	2008-08-19
24240	ORIG	2008-08-19
6862	ORIG	2008-07-15
38216	ORIG	2008-07-09
51148	ORIG	1900-01-01
51147	ORIG	1900-01-01