Application 020923

Type: NDA
Sponsor: LIEBEL-FLARSHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPTIRAY 240	IOVERSOL	INJECTABLE;INJECTION	51%	No	No
002	OPTIRAY 320	IOVERSOL	INJECTABLE;INJECTION	68%	Yes	Yes
003	OPTIRAY 350	IOVERSOL	INJECTABLE;INJECTION	74%	Yes	Yes
004	OPTIRAY 300	IOVERSOL	INJECTABLE;INJECTION	64%	Yes	Yes

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
N020923-001	OPTIRAY 240	IOVERSOL	51%	INJECTABLE / INJECTION		1998-05-28
N020923-002	OPTIRAY 320	IOVERSOL	68%	INJECTABLE / INJECTION	RLD, RS	1998-05-29
N020923-003	OPTIRAY 350	IOVERSOL	74%	INJECTABLE / INJECTION	RLD, RS	1998-05-28
N020923-004	OPTIRAY 300	IOVERSOL	64%	INJECTABLE / INJECTION	RLD	1999-05-13

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	N020923-001	OPTIRAY 240	51%	INJECTABLE / INJECTION		1998-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020923-002	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1998-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020923-003	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1998-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020923-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1999-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020923-001	OPTIRAY 240	51%	INJECTABLE / INJECTION		1998-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020923-002	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1998-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020923-003	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1998-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020923-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1999-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020923-001	OPTIRAY 240	51%	INJECTABLE / INJECTION		1998-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020923-002	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1998-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020923-003	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1998-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020923-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1999-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020923-001	OPTIRAY 240	51%	INJECTABLE / INJECTION		1998-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020923-002	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1998-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020923-003	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1998-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020923-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1999-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020923-001	OPTIRAY 240	51%	INJECTABLE / INJECTION		1998-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020923-002	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1998-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020923-003	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1998-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020923-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1999-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020923-001	OPTIRAY 240	51%	INJECTABLE / INJECTION		1998-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020923-002	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1998-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020923-003	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1998-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020923-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1999-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020923-001	OPTIRAY 240	51%	INJECTABLE / INJECTION		1998-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020923-002	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1998-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020923-003	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1998-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020923-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1999-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020923-001	OPTIRAY 240	51%	INJECTABLE / INJECTION		1998-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020923-002	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1998-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020923-003	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1998-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020923-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1999-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020923-001	OPTIRAY 240	51%	INJECTABLE / INJECTION		1998-05-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020923-002	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1998-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020923-003	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1998-05-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020923-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1999-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020923-001	OPTIRAY 240	51%	INJECTABLE / INJECTION		1998-05-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020923-002	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1998-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020923-003	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1998-05-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020923-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1999-05-13	`4b0b4de00fa7…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Optiray 320	IOVERSOL	Liebel-Flarsheim Company LLC	6cb6ca5f-b249-49b0-a9eb-8aa583da7c74	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020923 application number: NDA020923 ndc (product): 0019-1323 ndc (product): 0019-1333 ndc (product): 0019-1332
Optiray 320	IOVERSOL	Liebel-Flarsheim Company LLC	cd718d1c-f813-4114-a50d-c744ff7eb1bf	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020923 application number: NDA020923 ndc (product): 0019-1323 ndc (product): 0019-1333 ndc (product): 0019-1332
Optiray 320	IOVERSOL	Liebel-Flarsheim Company LLC	549d38db-d4ed-4708-8f76-7cdaa157063f	2023-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0019-1323 ndc (product): 0019-1333 ndc (product): 0019-1332

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0019-1323	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1323	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1323	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1323	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1323	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1323	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1332	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1332	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1332	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1332	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1332	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1332	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1333	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1333	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1333	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1333	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1333	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1333	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74088	SUPPL	2023-04-27
74076	SUPPL	2023-04-27
70228	SUPPL	2022-02-23
70218	SUPPL	2022-02-22
65293	SUPPL	2020-11-19
65288	SUPPL	2020-11-19
65286	SUPPL	2020-11-19
65285	SUPPL	2020-11-19
50743	SUPPL	2017-12-18
50678	SUPPL	2017-12-13
48210	SUPPL	2017-05-02
48136	SUPPL	2017-04-27
47962	SUPPL	2017-04-12
47876	SUPPL	2017-04-06
45075	SUPPL	2016-08-17
45132	SUPPL	2016-08-12
3762	SUPPL	2015-07-10
35652	SUPPL	2015-07-09
41814	ORIG	2004-03-09
35651	ORIG	1998-05-29
3761	ORIG	1998-05-28