Application 016517

Type: NDA
Sponsor: CURIUM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM IODIDE I 131	SODIUM IODIDE I-131	CAPSULE;ORAL	0.8-100mCi	Yes	No
002	SODIUM IODIDE I 131	SODIUM IODIDE I-131	CAPSULE;ORAL	15-100uCi	No	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
N016517-001	SODIUM IODIDE I 131	SODIUM IODIDE I-131	0.8-100mCi	CAPSULE / ORAL		RLD, Approved before 1982
N016517-002	SODIUM IODIDE I 131	SODIUM IODIDE I-131	15-100uCi	CAPSULE / ORAL		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	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016517-001	SODIUM IODIDE I 131	0.8-100mCi	CAPSULE / ORAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016517-002	SODIUM IODIDE I 131	15-100uCi	CAPSULE / ORAL	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
Sodium Iodide I-131	SODIUM IODIDE I-131	Radnostix, Inc.	380e8e26-0625-4233-b36e-afb9f66e8a77	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: SODIUM IODIDE I-131

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
52513	SUPPL	2018-02-08
52497	SUPPL	2018-02-07
10894	SUPPL	2015-10-22
13000	SUPPL	2015-10-21
10893	SUPPL	2014-03-25
453	SUPPL	2014-03-21
452	SUPPL	2012-02-07
33173	SUPPL	2012-02-06