Application 017630
- Type
- NDA
- Sponsor
- GE HEALTHCARE
Application Products#
| 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| SODIUM IODIDE I-123 | SOLUTION;ORAL | 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | 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IODIDE I 123 | SODIUM IODIDE I-123 | 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | Approved before 1982 | ||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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-02-18 07:12 UTC | 2024-02 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N017630-002 | SODIUM IODIDE I 123 | 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | 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 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | 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 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | 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 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | 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 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | 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 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | 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 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | 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 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | 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 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | 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 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | 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 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | 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 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N017630-001 | SODIUM IODIDE I 123 | 100uCi | CAPSULE / ORAL | Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | 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 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N017630-003 | SODIUM IODIDE I 123 | 200uCi | CAPSULE / ORAL | 1993-01-08 | 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.
| 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 | 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 | 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 |
|---|---|---|
| 13871 | SUPPL | 2005-06-21 |