Application 017630

Type: NDA
Sponsor: GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM IODIDE I 123	SODIUM IODIDE I-123	CAPSULE;ORAL	100uCi	No	No
002	SODIUM IODIDE I 123	SODIUM IODIDE I-123	SOLUTION;ORAL	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	SODIUM IODIDE I 123	SODIUM IODIDE I-123	CAPSULE;ORAL	200uCi	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N017630-001	SODIUM IODIDE I 123	SODIUM IODIDE I-123	100uCi	CAPSULE / ORAL	Approved before 1982
N017630-002	SODIUM IODIDE I 123	SODIUM IODIDE I-123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	Approved before 1982
N017630-003	SODIUM IODIDE I 123	SODIUM IODIDE I-123	200uCi	CAPSULE / ORAL		1993-01-08

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 3 · 118 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017630-003	SODIUM IODIDE I 123	200uCi	CAPSULE / ORAL		1993-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017630-003	SODIUM IODIDE I 123	200uCi	CAPSULE / ORAL		1993-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017630-003	SODIUM IODIDE I 123	200uCi	CAPSULE / ORAL		1993-01-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017630-003	SODIUM IODIDE I 123	200uCi	CAPSULE / ORAL		1993-01-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	Approved before 1982		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017630-002	SODIUM IODIDE I 123	2mCi/ML	SOLUTION / ORAL	Approved before 1982		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017630-002	SODIUM IODIDE I 123	2mCi/ML	SOLUTION / ORAL	Approved before 1982		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	Approved before 1982		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	Approved before 1982		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	Approved before 1982		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	Approved before 1982		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	Approved before 1982		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	Approved before 1982		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	Approved before 1982		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	Approved before 1982		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	Approved before 1982		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	Approved before 1982		`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017630-001	SODIUM IODIDE I 123	100uCi	CAPSULE / ORAL	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017630-002	SODIUM IODIDE I 123	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017630-003	SODIUM IODIDE I 123	200uCi	CAPSULE / ORAL		1993-01-08	`6a51e52b5d6a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM IODIDE I 123	SODIUM IODIDE I 123	Curium US LLC	493fa2ab-4eb0-4434-9739-3079b2f0e272	2024-10-17	Warnings, Adverse reactions	Name fallback brand name: SODIUM IODIDE I 123
Sodium Iodide I 123	SODIUM IODIDE I 123	Cardinal Health 418, Inc	50415c27-1928-4307-b1dc-648f47edf65d	2018-04-17	Warnings, Adverse reactions	Name fallback brand name: Sodium Iodide I 123

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
13871	SUPPL	2005-06-21