Application 013295

Type: NDA
Sponsor: LIEBEL-FLARSHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CONRAY	IOTHALAMATE MEGLUMINE	INJECTABLE;INJECTION	60%	Yes	Yes
002	CONRAY 43	IOTHALAMATE MEGLUMINE	INJECTABLE;INJECTION	43%	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
N013295-001	CONRAY	IOTHALAMATE MEGLUMINE	60%	INJECTABLE / INJECTION		RLD, Approved before 1982
N013295-002	CONRAY 43	IOTHALAMATE MEGLUMINE	43%	INJECTABLE / INJECTION		RLD, Approved before 1982

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	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N013295-001	CONRAY	60%	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N013295-002	CONRAY 43	43%	INJECTABLE / INJECTION	RLD, Approved before 1982	`3a93d1ddd44b…`

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
Cysto-Conray II	IOTHALAMATE MEGLUMINE	Liebel-Flarsheim Company LLC	8841ab4d-674d-4beb-88a5-13e35f6005cc	2020-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IOTHALAMATE MEGLUMINE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0019-0953	Conray	iothalamate meglumine	Liebel-Flarsheim Company LLC	NDA	Current
0019-0953	Conray	iothalamate meglumine	Liebel-Flarsheim Company LLC	NDA	Current
0019-0953	Conray	iothalamate meglumine	Liebel-Flarsheim Company LLC	NDA	Current
0019-0953	Conray	iothalamate meglumine	Liebel-Flarsheim Company LLC	NDA	Current
0019-3183	Conray 43	iothalamate meglumine	Liebel-Flarsheim Company LLC	NDA	Current
0019-3183	Conray 43	iothalamate meglumine	Liebel-Flarsheim Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74104	SUPPL	2023-04-27
74092	SUPPL	2023-04-27
70226	SUPPL	2022-02-23
70213	SUPPL	2022-02-22
47971	SUPPL	2017-04-12
47880	SUPPL	2017-04-06
12050	SUPPL	2015-07-10
33105	SUPPL	2015-07-09
361	SUPPL	2014-07-10
360	SUPPL	2003-06-22