Application 018735
- Type
- NDA
- Sponsor
- BRACCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOVUE-M 200 | IOPAMIDOL | INJECTABLE;INJECTION | 41% | Yes | Yes |
| 002 | ISOVUE-300 | IOPAMIDOL | INJECTABLE;INJECTION | 61% | Yes | Yes |
| 003 | ISOVUE-370 | IOPAMIDOL | INJECTABLE;INJECTION | 76% | Yes | Yes |
| 004 | ISOVUE-M 300 | IOPAMIDOL | INJECTABLE;INJECTION | 61% | Yes | Yes |
| 005 | ISOVUE-128 | IOPAMIDOL | INJECTABLE;INJECTION | 26% | No | No |
| 006 | ISOVUE-200 | IOPAMIDOL | INJECTABLE;INJECTION | 41% | Yes | Yes |
| 007 | ISOVUE-250 | IOPAMIDOL | INJECTABLE;INJECTION | 51% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0270-1314 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1314 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1314 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1314 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1314 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1314 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1314 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1315 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1315 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1315 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1315 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1315 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1315 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1315 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1316 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1316 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1316 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1316 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1316 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1316 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1316 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1317 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1317 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1317 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1317 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1317 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1317 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1317 | ISOVUE | IOPAMIDOL | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-1411 | ISOVUE-M | IOPAMIDOL | Bracco Diagnostics Inc | NDA | Current |
| 0270-1411 | ISOVUE-M | IOPAMIDOL | Bracco Diagnostics Inc | NDA | Current |
| 0270-1411 | ISOVUE-M | IOPAMIDOL | Bracco Diagnostics Inc | NDA | Current |
| 0270-1411 | ISOVUE-M | IOPAMIDOL | Bracco Diagnostics Inc | NDA | Current |
| 0270-1412 | ISOVUE-M | IOPAMIDOL | Bracco Diagnostics Inc | NDA | Current |
| 0270-1412 | ISOVUE-M | IOPAMIDOL | Bracco Diagnostics Inc | NDA | Current |
| 0270-1412 | ISOVUE-M | IOPAMIDOL | Bracco Diagnostics Inc | NDA | Current |
| 0270-1412 | ISOVUE-M | IOPAMIDOL | Bracco Diagnostics Inc | NDA | Current |
| 52584-411 | ISOVUE-M 200 | Iopamidol | General Injectables & Vaccines, Inc. | NDA | Current |
| 76381-314 | ISOVUE | IOPAMIDOL | BIPSO GmbH | NDA | Current |
| 76381-315 | ISOVUE | IOPAMIDOL | BIPSO GmbH | NDA | Current |
| 76381-316 | ISOVUE | IOPAMIDOL | BIPSO GmbH | NDA | Current |
| 76381-317 | ISOVUE | IOPAMIDOL | BIPSO GmbH | NDA | Current |
| 76381-411 | ISOVUE-M | IOPAMIDOL | BIPSO GmbH | NDA | Current |
| 76381-412 | ISOVUE-M | IOPAMIDOL | BIPSO GmbH | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84775 | SUPPL | 2026-01-20 |
| 84755 | SUPPL | 2026-01-15 |
| 83769 | SUPPL | 2025-10-15 |
| 83768 | SUPPL | 2025-10-15 |
| 83752 | SUPPL | 2025-10-15 |
| 83751 | SUPPL | 2025-10-15 |
| 80542 | SUPPL | 2024-12-10 |
| 80536 | SUPPL | 2024-12-09 |
| 74071 | SUPPL | 2023-04-27 |
| 74067 | SUPPL | 2023-04-26 |
| 70250 | SUPPL | 2022-02-24 |
| 70221 | SUPPL | 2022-02-22 |
| 47969 | SUPPL | 2017-04-12 |
| 47882 | SUPPL | 2017-04-06 |
| 33586 | SUPPL | 2015-07-09 |
| 16020 | SUPPL | 2015-07-09 |
| 16019 | SUPPL | 2012-08-03 |
| 33585 | SUPPL | 2012-08-02 |
| 16018 | SUPPL | 2002-07-08 |
| 1057 | SUPPL | 2002-06-20 |