Application 020976

Type: NDA
Sponsor: LIEBEL-FLARSHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	INJECTABLE;INJECTION	9927MG/30ML (330.9MG/ML)	Yes	No
002	OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	INJECTABLE;INJECTION	3309MG/10ML (330.9MG/ML)	Yes	No
003	OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	INJECTABLE;INJECTION	4963.5MG/15ML (330.9MG/ML)	Yes	No
004	OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	INJECTABLE;INJECTION	6618MG/20ML (330.9MG/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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020976-001	OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	9927MG/30ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08
N020976-002	OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	3309MG/10ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08
N020976-003	OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	4963.5MG/15ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08
N020976-004	OPTIMARK IN PLASTIC CONTAINER	GADOVERSETAMIDE	6618MG/20ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08

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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020976-001	OPTIMARK IN PLASTIC CONTAINER	9927MG/30ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020976-002	OPTIMARK IN PLASTIC CONTAINER	3309MG/10ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020976-003	OPTIMARK IN PLASTIC CONTAINER	4963.5MG/15ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020976-004	OPTIMARK IN PLASTIC CONTAINER	6618MG/20ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020976-001	OPTIMARK IN PLASTIC CONTAINER	9927MG/30ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020976-002	OPTIMARK IN PLASTIC CONTAINER	3309MG/10ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020976-003	OPTIMARK IN PLASTIC CONTAINER	4963.5MG/15ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020976-004	OPTIMARK IN PLASTIC CONTAINER	6618MG/20ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020976-001	OPTIMARK IN PLASTIC CONTAINER	9927MG/30ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020976-002	OPTIMARK IN PLASTIC CONTAINER	3309MG/10ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020976-003	OPTIMARK IN PLASTIC CONTAINER	4963.5MG/15ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020976-004	OPTIMARK IN PLASTIC CONTAINER	6618MG/20ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020976-001	OPTIMARK IN PLASTIC CONTAINER	9927MG/30ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020976-002	OPTIMARK IN PLASTIC CONTAINER	3309MG/10ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020976-003	OPTIMARK IN PLASTIC CONTAINER	4963.5MG/15ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020976-004	OPTIMARK IN PLASTIC CONTAINER	6618MG/20ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020976-001	OPTIMARK IN PLASTIC CONTAINER	9927MG/30ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020976-002	OPTIMARK IN PLASTIC CONTAINER	3309MG/10ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020976-003	OPTIMARK IN PLASTIC CONTAINER	4963.5MG/15ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020976-004	OPTIMARK IN PLASTIC CONTAINER	6618MG/20ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020976-001	OPTIMARK IN PLASTIC CONTAINER	9927MG/30ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020976-002	OPTIMARK IN PLASTIC CONTAINER	3309MG/10ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020976-003	OPTIMARK IN PLASTIC CONTAINER	4963.5MG/15ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020976-004	OPTIMARK IN PLASTIC CONTAINER	6618MG/20ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020976-001	OPTIMARK IN PLASTIC CONTAINER	9927MG/30ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020976-002	OPTIMARK IN PLASTIC CONTAINER	3309MG/10ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020976-003	OPTIMARK IN PLASTIC CONTAINER	4963.5MG/15ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020976-004	OPTIMARK IN PLASTIC CONTAINER	6618MG/20ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020976-001	OPTIMARK IN PLASTIC CONTAINER	9927MG/30ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020976-002	OPTIMARK IN PLASTIC CONTAINER	3309MG/10ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020976-003	OPTIMARK IN PLASTIC CONTAINER	4963.5MG/15ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020976-004	OPTIMARK IN PLASTIC CONTAINER	6618MG/20ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020976-001	OPTIMARK IN PLASTIC CONTAINER	9927MG/30ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020976-002	OPTIMARK IN PLASTIC CONTAINER	3309MG/10ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020976-003	OPTIMARK IN PLASTIC CONTAINER	4963.5MG/15ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020976-004	OPTIMARK IN PLASTIC CONTAINER	6618MG/20ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020976-001	OPTIMARK IN PLASTIC CONTAINER	9927MG/30ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020976-002	OPTIMARK IN PLASTIC CONTAINER	3309MG/10ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020976-003	OPTIMARK IN PLASTIC CONTAINER	4963.5MG/15ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020976-004	OPTIMARK IN PLASTIC CONTAINER	6618MG/20ML (330.9MG/ML)	INJECTABLE / INJECTION	RLD	1999-12-08	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56433	SUPPL	2018-11-14
56290	SUPPL	2018-11-06
56289	SUPPL	2018-11-06
53898	SUPPL	2018-05-01
53844	SUPPL	2018-04-27
53843	SUPPL	2018-04-27
45220	SUPPL	2016-08-29
26347	SUPPL	2014-11-26
14062	SUPPL	2014-11-26
26346	SUPPL	2014-08-11
35761	SUPPL	2014-08-08
35760	SUPPL	2013-08-27
26345	SUPPL	2013-08-27
35759	SUPPL	2013-05-23
3902	SUPPL	2013-05-23
3901	SUPPL	2010-12-22
14061	SUPPL	2010-12-20
14060	SUPPL	2007-09-06
3900	SUPPL	2007-09-06
26344	SUPPL	2006-08-07
14059	SUPPL	2006-08-07
23612	ORIG	2006-06-09
26343	SUPPL	2005-11-30
35758	SUPPL	2004-06-10
26342	SUPPL	2004-06-10
21320	SUPPL	2004-01-29
41853	ORIG	1999-12-08
26341	ORIG	1999-12-08
14058	ORIG	1999-12-08