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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N010929-001 | IODOTOPE | 1-130mCi | CAPSULE / ORAL | Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N010929-002 | IODOTOPE | 7-106mCi/BOT | SOLUTION / ORAL | Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N010929-003 | IODOTOPE | 1-150mCi | CAPSULE / ORAL | Approved before 1982 | 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-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.