Application 217134
- Type
- ANDA
- Sponsor
- HAINAN POLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IOPAMIDOL | IOPAMIDOL | INJECTABLE;INJECTION | 41% | No | No |
| 002 | IOPAMIDOL | IOPAMIDOL | INJECTABLE;INJECTION | 51% | No | No |
| 003 | IOPAMIDOL | IOPAMIDOL | INJECTABLE;INJECTION | 61% | No | No |
| 004 | IOPAMIDOL | IOPAMIDOL | INJECTABLE;INJECTION | 76% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217134-001 | IOPAMIDOL | IOPAMIDOL | 41% | INJECTABLE / INJECTION | AP2 | 2023-09-27 | |
| A217134-002 | IOPAMIDOL | IOPAMIDOL | 51% | INJECTABLE / INJECTION | AP | 2024-04-09 | |
| A217134-003 | IOPAMIDOL | IOPAMIDOL | 61% | INJECTABLE / INJECTION | AP | 2024-04-09 | |
| A217134-004 | IOPAMIDOL | IOPAMIDOL | 76% | INJECTABLE / INJECTION | AP | 2024-04-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217134-001 | AP2 |
| A217134-002 | AP |
| A217134-003 | AP |
| A217134-004 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A217134-001 | IOPAMIDOL | 41% | INJECTABLE / INJECTION | AP2 | 2023-09-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A217134-002 | IOPAMIDOL | 51% | INJECTABLE / INJECTION | AP | 2024-04-09 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A217134-003 | IOPAMIDOL | 61% | INJECTABLE / INJECTION | AP | 2024-04-09 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A217134-004 | IOPAMIDOL | 76% | INJECTABLE / INJECTION | AP | 2024-04-09 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A217134-001 | IOPAMIDOL | 41% | INJECTABLE / INJECTION | AP2 | 2023-09-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217134-002 | IOPAMIDOL | 51% | INJECTABLE / INJECTION | AP | 2024-04-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217134-003 | IOPAMIDOL | 61% | INJECTABLE / INJECTION | AP | 2024-04-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217134-004 | IOPAMIDOL | 76% | INJECTABLE / INJECTION | AP | 2024-04-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A217134-001 | IOPAMIDOL | 41% | INJECTABLE / INJECTION | AP2 | 2023-09-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217134-002 | IOPAMIDOL | 51% | INJECTABLE / INJECTION | AP | 2024-04-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217134-003 | IOPAMIDOL | 61% | INJECTABLE / INJECTION | AP | 2024-04-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217134-004 | IOPAMIDOL | 76% | INJECTABLE / INJECTION | AP | 2024-04-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217134-001 | IOPAMIDOL | 41% | INJECTABLE / INJECTION | AP2 | 2023-09-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217134-002 | IOPAMIDOL | 51% | INJECTABLE / INJECTION | AP | 2024-04-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217134-003 | IOPAMIDOL | 61% | INJECTABLE / INJECTION | AP | 2024-04-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217134-004 | IOPAMIDOL | 76% | INJECTABLE / INJECTION | AP | 2024-04-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217134-001 | IOPAMIDOL | 41% | INJECTABLE / INJECTION | AP2 | 2023-09-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217134-002 | IOPAMIDOL | 51% | INJECTABLE / INJECTION | AP | 2024-04-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217134-003 | IOPAMIDOL | 61% | INJECTABLE / INJECTION | AP | 2024-04-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217134-004 | IOPAMIDOL | 76% | INJECTABLE / INJECTION | AP | 2024-04-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217134-001 | IOPAMIDOL | 41% | INJECTABLE / INJECTION | AP2 | 2023-09-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217134-002 | IOPAMIDOL | 51% | INJECTABLE / INJECTION | AP | 2024-04-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217134-003 | IOPAMIDOL | 61% | INJECTABLE / INJECTION | AP | 2024-04-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217134-004 | IOPAMIDOL | 76% | INJECTABLE / INJECTION | AP | 2024-04-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217134-001 | IOPAMIDOL | 41% | INJECTABLE / INJECTION | AP2 | 2023-09-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217134-002 | IOPAMIDOL | 51% | INJECTABLE / INJECTION | AP | 2024-04-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217134-003 | IOPAMIDOL | 61% | INJECTABLE / INJECTION | AP | 2024-04-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217134-004 | IOPAMIDOL | 76% | INJECTABLE / INJECTION | AP | 2024-04-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217134-001 | IOPAMIDOL | 41% | INJECTABLE / INJECTION | AP2 | 2023-09-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217134-002 | IOPAMIDOL | 51% | INJECTABLE / INJECTION | AP | 2024-04-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217134-003 | IOPAMIDOL | 61% | INJECTABLE / INJECTION | AP | 2024-04-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217134-004 | IOPAMIDOL | 76% | INJECTABLE / INJECTION | AP | 2024-04-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217134-001 | IOPAMIDOL | 41% | INJECTABLE / INJECTION | AP2 | 2023-09-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217134-002 | IOPAMIDOL | 51% | INJECTABLE / INJECTION | AP | 2024-04-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217134-003 | IOPAMIDOL | 61% | INJECTABLE / INJECTION | AP | 2024-04-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217134-004 | IOPAMIDOL | 76% | INJECTABLE / INJECTION | AP | 2024-04-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217134-001 | IOPAMIDOL | 41% | INJECTABLE / INJECTION | AP2 | 2023-09-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217134-002 | IOPAMIDOL | 51% | INJECTABLE / INJECTION | AP | 2024-04-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217134-003 | IOPAMIDOL | 61% | INJECTABLE / INJECTION | AP | 2024-04-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217134-004 | IOPAMIDOL | 76% | INJECTABLE / INJECTION | AP | 2024-04-09 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A217134-001 | AP2 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A217134-002 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A217134-003 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A217134-004 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A217134-001 | AP2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217134-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217134-003 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217134-004 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A217134-001 | AP2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217134-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217134-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217134-004 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217134-001 | AP2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217134-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217134-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217134-004 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217134-001 | AP2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217134-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217134-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217134-004 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217134-001 | AP2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217134-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217134-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217134-004 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217134-001 | AP2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217134-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217134-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217134-004 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217134-001 | AP2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217134-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217134-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217134-004 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217134-001 | AP2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217134-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217134-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217134-004 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217134-001 | AP2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217134-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217134-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217134-004 | 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 |
|---|---|---|---|---|---|---|
| iopamidol | IOPAMIDOL | Slate Run Pharmaceuticals, LLC | 0b9e0d24-c6ca-4e22-9422-936e9d475eaa | 2026-07-23 | Warnings, Adverse reactions | iopamidol IOPAMIDOL |
| ISOVUE 200 | IOPAMIDOL | BRACCO DIAGNOSTICS INC | ae8c18c9-3e7d-4515-b980-120025a88fc1 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | IOPAMIDOL |
| ISOVUE 300 | IOPAMIDOL | Bracco Diagnostics Inc | 797a11d7-dcd4-43ff-311b-3b48a10da2f2 | 2026-02-14 | Boxed warning, Warnings, Adverse reactions | IOPAMIDOL |
| ISOVUE-M | IOPAMIDOL | Bracco Diagnostics Inc | 11e893d2-0183-4581-b908-c8b7302c7edb | 2026-02-10 | Warnings, Adverse reactions | IOPAMIDOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75956 | ORIG | 2023-10-27 |