Application 022290
- Type
- NDA
- Sponsor
- GE HEALTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADREVIEW | IOBENGUANE SULFATE I-123 | SOLUTION;INTRAVENOUS | 10mCi/5ML (2mCi/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022290-001 | ADREVIEW | IOBENGUANE SULFATE I-123 | 10mCi/5ML (2mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2008-09-19 |
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 | N022290-001 | ADREVIEW | 10mCi/5ML (2mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2008-09-19 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N022290-001 | ADREVIEW | 10mCi/5ML (2mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2008-09-19 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022290-001 | ADREVIEW | 10mCi/5ML (2mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2008-09-19 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022290-001 | ADREVIEW | 10mCi/5ML (2mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2008-09-19 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022290-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022290-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022290-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022290-001 | AP | 1 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| AdreView | IOBENGUANE I-123 | Medi-Physics Inc. | c89d3ecc-4f4c-4566-8808-79152344194d | 2024-01-10 | Warnings, Adverse reactions | 022290 NDA022290 17156-235 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17156-235 | AdreView | Iobenguane I-123 | Medi-Physics Inc. | NDA | Current |
| 17156-235 | AdreView | Iobenguane I-123 | Medi-Physics Inc. | NDA | Current |
| 17156-235 | AdreView | Iobenguane I-123 | Medi-Physics Inc. | NDA | Current |
| 17156-235 | AdreView | Iobenguane I-123 | Medi-Physics Inc. | NDA | Current |