Application 010929
- Type
- NDA
- Sponsor
- BRACCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IODOTOPE | SODIUM IODIDE I-131 | CAPSULE;ORAL | 1-130mCi | No | No |
| 002 | IODOTOPE | SODIUM IODIDE I-131 | SOLUTION;ORAL | 7-106mCi/BOT | No | No |
| 003 | IODOTOPE | SODIUM IODIDE I-131 | CAPSULE;ORAL | 1-150mCi | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N010929-001 | IODOTOPE | SODIUM IODIDE I-131 | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | ||
| N010929-002 | IODOTOPE | SODIUM IODIDE I-131 | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | ||
| N010929-003 | IODOTOPE | SODIUM IODIDE I-131 | 1-150mCi | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2020-11-12 02:37 UTC | 2020-11 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N010929-003 | IODOTOPE | 1-150mCi | 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.
| 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 | SODIUM IODIDE I-131 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.