Application 216017
- Type
- NDA
- Sponsor
- BRACCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 25GM IODINE/100ML (250MG IODINE/ML) | Yes | No |
| 002 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 15GM IODINE/50ML (300MG IODINE/ML) | Yes | No |
| 003 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 30GM IODINE/100ML (300MG IODINE/ML) | Yes | No |
| 004 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 45GM IODINE/150ML (300MG IODINE/ML) | Yes | No |
| 005 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 60GM IODINE/200ML (300MG IODINE/ML) | Yes | No |
| 006 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 17.5GM IODINE/50ML (350MG IODINE/ML) | Yes | No |
| 007 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 35GM IODINE/100ML (350MG IODINE/ML) | Yes | Yes |
| 008 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 52.5GM IODINE/150ML (350MG IODINE/ML) | Yes | No |
| 009 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 70GM IODINE/200ML (350MG IODINE/ML) | Yes | Yes |
| 010 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 20GM IODINE/50ML (400MG IODINE/ML) | Yes | No |
| 011 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 40GM IODINE/100ML (400MG IODINE/ML) | Yes | Yes |
| 012 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 60GM IODINE/150ML (400MG IODINE/ML) | Yes | No |
| 013 | IOMERVU | IOMEPROL | SOLUTION;INTRAVENOUS | 80GM IODINE/200ML (400MG IODINE/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216017-001 | IOMERVU | IOMEPROL | 25GM IODINE/100ML (250MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | |
| N216017-002 | IOMERVU | IOMEPROL | 15GM IODINE/50ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | |
| N216017-003 | IOMERVU | IOMEPROL | 30GM IODINE/100ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | |
| N216017-004 | IOMERVU | IOMEPROL | 45GM IODINE/150ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | |
| N216017-005 | IOMERVU | IOMEPROL | 60GM IODINE/200ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | |
| N216017-006 | IOMERVU | IOMEPROL | 17.5GM IODINE/50ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | |
| N216017-007 | IOMERVU | IOMEPROL | 35GM IODINE/100ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-11-27 | |
| N216017-008 | IOMERVU | IOMEPROL | 52.5GM IODINE/150ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | |
| N216017-009 | IOMERVU | IOMEPROL | 70GM IODINE/200ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-11-27 | |
| N216017-010 | IOMERVU | IOMEPROL | 20GM IODINE/50ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | |
| N216017-011 | IOMERVU | IOMEPROL | 40GM IODINE/100ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-11-27 | |
| N216017-012 | IOMERVU | IOMEPROL | 60GM IODINE/150ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | |
| N216017-013 | IOMERVU | IOMEPROL | 80GM IODINE/200ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-11-27 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N216017-001 | NCE | 2029-11-27 |
| N216017-002 | NCE | 2029-11-27 |
| N216017-003 | NCE | 2029-11-27 |
| N216017-004 | NCE | 2029-11-27 |
| N216017-005 | NCE | 2029-11-27 |
| N216017-006 | NCE | 2029-11-27 |
| N216017-007 | NCE | 2029-11-27 |
| N216017-008 | NCE | 2029-11-27 |
| N216017-009 | NCE | 2029-11-27 |
| N216017-010 | NCE | 2029-11-27 |
| N216017-011 | NCE | 2029-11-27 |
| N216017-012 | NCE | 2029-11-27 |
| N216017-013 | NCE | 2029-11-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N216017-001 | IOMERVU | 25GM IODINE/100ML (250MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-002 | IOMERVU | 15GM IODINE/50ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-003 | IOMERVU | 30GM IODINE/100ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-004 | IOMERVU | 45GM IODINE/150ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-005 | IOMERVU | 60GM IODINE/200ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-006 | IOMERVU | 17.5GM IODINE/50ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-007 | IOMERVU | 35GM IODINE/100ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-008 | IOMERVU | 52.5GM IODINE/150ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-009 | IOMERVU | 70GM IODINE/200ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-010 | IOMERVU | 20GM IODINE/50ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-011 | IOMERVU | 40GM IODINE/100ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-012 | IOMERVU | 60GM IODINE/150ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-013 | IOMERVU | 80GM IODINE/200ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-001 | IOMERVU | 25GM IODINE/100ML (250MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-002 | IOMERVU | 15GM IODINE/50ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-003 | IOMERVU | 30GM IODINE/100ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-004 | IOMERVU | 45GM IODINE/150ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-005 | IOMERVU | 60GM IODINE/200ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-006 | IOMERVU | 17.5GM IODINE/50ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-007 | IOMERVU | 35GM IODINE/100ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-008 | IOMERVU | 52.5GM IODINE/150ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-009 | IOMERVU | 70GM IODINE/200ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-010 | IOMERVU | 20GM IODINE/50ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-011 | IOMERVU | 40GM IODINE/100ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-012 | IOMERVU | 60GM IODINE/150ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-013 | IOMERVU | 80GM IODINE/200ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-001 | IOMERVU | 25GM IODINE/100ML (250MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-002 | IOMERVU | 15GM IODINE/50ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-003 | IOMERVU | 30GM IODINE/100ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-004 | IOMERVU | 45GM IODINE/150ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-005 | IOMERVU | 60GM IODINE/200ML (300MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-006 | IOMERVU | 17.5GM IODINE/50ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-007 | IOMERVU | 35GM IODINE/100ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-008 | IOMERVU | 52.5GM IODINE/150ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-009 | IOMERVU | 70GM IODINE/200ML (350MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-010 | IOMERVU | 20GM IODINE/50ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-011 | IOMERVU | 40GM IODINE/100ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-012 | IOMERVU | 60GM IODINE/150ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-013 | IOMERVU | 80GM IODINE/200ML (400MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-11-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216017-001 | IOMERVU | 25GM IODINE/100ML (250MG IODINE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-11-27 | fd3edfee7708… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N216017-001 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-002 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-003 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-004 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-005 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-006 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-007 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-008 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-009 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-010 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-011 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-012 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216017-013 | NCE | 2029-11-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-001 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-002 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-003 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-004 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-005 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-006 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-007 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-008 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-009 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-010 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-011 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-012 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216017-013 | NCE | 2029-11-27 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-001 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-002 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-003 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-004 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-005 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-006 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-007 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-008 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-009 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-010 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-011 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-012 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216017-013 | NCE | 2029-11-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216017-001 | NCE | 2029-11-27 | fd3edfee7708… |
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 |
|---|---|---|---|---|---|---|
| IOMERVU | IOMEPROL INJECTION | BRACCO DIAGNOSTICS INC | cb2e0e00-7c93-0fb4-89a5-861641662a5a | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | IOMERVU |