Application 019710

Type: NDA
Sponsor: LIEBEL-FLARSHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPTIRAY 320	IOVERSOL	INJECTABLE;INJECTION	68%	Yes	Yes
002	OPTIRAY 240	IOVERSOL	INJECTABLE;INJECTION	51%	Yes	Yes
003	OPTIRAY 160	IOVERSOL	INJECTABLE;INJECTION	34%	No	No
004	OPTIRAY 300	IOVERSOL	INJECTABLE;INJECTION	64%	Yes	Yes
005	OPTIRAY 350	IOVERSOL	INJECTABLE;INJECTION	74%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019710-001	OPTIRAY 320	IOVERSOL	68%	INJECTABLE / INJECTION	RLD, RS	1988-12-30
N019710-002	OPTIRAY 240	IOVERSOL	51%	INJECTABLE / INJECTION	RLD	1988-12-30
N019710-003	OPTIRAY 160	IOVERSOL	34%	INJECTABLE / INJECTION		1988-12-30
N019710-004	OPTIRAY 300	IOVERSOL	64%	INJECTABLE / INJECTION	RLD, RS	1992-01-22
N019710-005	OPTIRAY 350	IOVERSOL	74%	INJECTABLE / INJECTION	RLD, RS	1992-01-22

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 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019710-001	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019710-002	OPTIRAY 240	51%	INJECTABLE / INJECTION	RLD	1988-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019710-003	OPTIRAY 160	34%	INJECTABLE / INJECTION		1988-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019710-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019710-005	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019710-001	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019710-002	OPTIRAY 240	51%	INJECTABLE / INJECTION	RLD	1988-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019710-003	OPTIRAY 160	34%	INJECTABLE / INJECTION		1988-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019710-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019710-005	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019710-001	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019710-002	OPTIRAY 240	51%	INJECTABLE / INJECTION	RLD	1988-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019710-003	OPTIRAY 160	34%	INJECTABLE / INJECTION		1988-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019710-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019710-005	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019710-001	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019710-002	OPTIRAY 240	51%	INJECTABLE / INJECTION	RLD	1988-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019710-003	OPTIRAY 160	34%	INJECTABLE / INJECTION		1988-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019710-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019710-005	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019710-001	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019710-002	OPTIRAY 240	51%	INJECTABLE / INJECTION	RLD	1988-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019710-003	OPTIRAY 160	34%	INJECTABLE / INJECTION		1988-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019710-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019710-005	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019710-001	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019710-002	OPTIRAY 240	51%	INJECTABLE / INJECTION	RLD	1988-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019710-003	OPTIRAY 160	34%	INJECTABLE / INJECTION		1988-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019710-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019710-005	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019710-001	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019710-002	OPTIRAY 240	51%	INJECTABLE / INJECTION	RLD	1988-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019710-003	OPTIRAY 160	34%	INJECTABLE / INJECTION		1988-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019710-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019710-005	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019710-001	OPTIRAY 320	68%	INJECTABLE / INJECTION	RLD, RS	1988-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019710-002	OPTIRAY 240	51%	INJECTABLE / INJECTION	RLD	1988-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019710-003	OPTIRAY 160	34%	INJECTABLE / INJECTION		1988-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019710-004	OPTIRAY 300	64%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019710-005	OPTIRAY 350	74%	INJECTABLE / INJECTION	RLD, RS	1992-01-22	`03ed91905a0d…`

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 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 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 application applno (NDA): 019710 application number: NDA019710 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 · 28 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
0019-1323	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1323	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1324	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1324	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1324	Optiray	Ioversol	Liebel-Flarsheim Company LLC	NDA	Current
0019-1324	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
0019-1332	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
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
74087	SUPPL	2023-04-27
74075	SUPPL	2023-04-27
71021	SUPPL	2022-05-06
71002	SUPPL	2022-05-05
70227	SUPPL	2022-02-23
70217	SUPPL	2022-02-22
61644	SUPPL	2020-01-24
61631	SUPPL	2020-01-24
48211	SUPPL	2017-05-02
48135	SUPPL	2017-04-27
47963	SUPPL	2017-04-12
47877	SUPPL	2017-04-06
45076	SUPPL	2016-08-17
45131	SUPPL	2016-08-12
1519	SUPPL	2015-07-10
11643	SUPPL	2015-07-09
1518	SUPPL	2008-04-30
19111	SUPPL	2008-04-28
20300	SUPPL	1997-05-23