Application 019044

Type: NDA
Sponsor: GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDIUM IN 111 OXYQUINOLINE	INDIUM IN-111 OXYQUINOLINE	INJECTABLE;INJECTION	1mCi/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019044-001	INDIUM IN 111 OXYQUINOLINE	INDIUM IN-111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019044-001	AP

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION		RLD, RS	1985-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION		RLD, RS	1985-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION		RLD, RS	1985-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION		RLD, RS	1985-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019044-001	INDIUM IN 111 OXYQUINOLINE	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019044-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019044-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019044-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019044-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019044-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019044-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019044-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019044-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019044-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019044-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019044-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019044-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019044-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019044-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019044-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019044-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019044-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019044-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N019044-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019044-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019044-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019044-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019044-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019044-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019044-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019044-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019044-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019044-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019044-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019044-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019044-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019044-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019044-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019044-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019044-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019044-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019044-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019044-001	AP	1	`a50c72e98297…`

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
Indium in 111 Oxyquinoline	INDIUM IN-111 OXYQUINOLINE	Medi-Physics Inc. dba GE Healthcare.	4c52c904-8137-4b10-8a85-d9b96c2d8a00	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019044 application number: NDA019044 ndc (product): 17156-021

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17156-021	Indium in 111 Oxyquinoline	Indium In-111 Oxyquinoline	Medi-Physics Inc. dba GE Healthcare.	NDA	Current
17156-021	Indium in 111 Oxyquinoline	Indium In-111 Oxyquinoline	Medi-Physics Inc. dba GE Healthcare.	NDA	Current
17156-021	Indium in 111 Oxyquinoline	Indium In-111 Oxyquinoline	Medi-Physics Inc. dba GE Healthcare.	NDA	Current
17156-021	Indium in 111 Oxyquinoline	Indium In-111 Oxyquinoline	Medi-Physics Inc. dba GE Healthcare.	NDA	Current
17156-021	Indium in 111 Oxyquinoline	Indium In-111 Oxyquinoline	Medi-Physics Inc. dba GE Healthcare.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72876	SUPPL	2022-12-13
72871	SUPPL	2022-12-13
11424	ORIG	2014-11-18
40869	SUPPL	2012-03-27
40868	SUPPL	2012-03-27
40870	SUPPL	2011-02-15
40867	SUPPL	2011-02-15
40866	SUPPL	2011-02-15
40865	SUPPL	2011-02-15
40864	SUPPL	2011-02-15
40863	SUPPL	2011-02-15
20203	SUPPL	2011-02-15
20202	SUPPL	2011-02-15
20201	SUPPL	2011-02-15
20200	SUPPL	2011-02-15
20199	SUPPL	2011-02-15
1215	SUPPL	2002-09-19