Application 018956
- Type
- NDA
- Sponsor
- GE HEALTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMNIPAQUE 180 | IOHEXOL | SOLUTION;INJECTION, ORAL, RECTAL | 38.8% | Yes | Yes |
| 002 | OMNIPAQUE 240 | IOHEXOL | SOLUTION;INJECTION, ORAL, RECTAL | 51.8% | Yes | Yes |
| 003 | OMNIPAQUE 300 | IOHEXOL | SOLUTION;INJECTION, ORAL, RECTAL | 64.7% | Yes | Yes |
| 004 | OMNIPAQUE 350 | IOHEXOL | SOLUTION;INJECTION, ORAL | 75.5% | Yes | Yes |
| 005 | OMNIPAQUE 140 | IOHEXOL | INJECTABLE;INJECTION | 30.2% | Yes | Yes |
| 006 | OMNIPAQUE 210 | IOHEXOL | INJECTABLE;INJECTION | 45.3% | No | No |
| 007 | OMNIPAQUE 70 | IOHEXOL | SOLUTION;URETHRAL | 15.1% | No | No |
| 008 | OMNIPAQUE 9 | IOHEXOL | SOLUTION;ORAL | 1.9% | Yes | Yes |
| 009 | OMNIPAQUE 12 | IOHEXOL | SOLUTION;ORAL | 2.6% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0407-1401 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1401 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1401 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1401 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1411 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1411 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1411 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1411 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1412 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1412 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1412 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1412 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1412 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1412 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1412 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1412 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1412 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1415 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1415 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1415 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1415 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1416 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1416 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1416 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1416 | OMNIPAQUE | Iohexol | GE Healthcare Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79850 | SUPPL | 2024-10-10 |
| 79842 | SUPPL | 2024-10-09 |
| 74082 | SUPPL | 2023-04-27 |
| 74073 | SUPPL | 2023-04-27 |
| 70268 | SUPPL | 2022-02-25 |
| 70219 | SUPPL | 2022-02-22 |
| 68311 | SUPPL | 2021-08-06 |
| 68304 | SUPPL | 2021-08-06 |
| 65971 | SUPPL | 2021-01-25 |
| 65157 | SUPPL | 2020-11-05 |
| 63801 | SUPPL | 2020-07-06 |
| 63800 | SUPPL | 2020-07-06 |
| 53761 | SUPPL | 2018-04-20 |
| 53733 | SUPPL | 2018-04-19 |
| 47966 | SUPPL | 2017-04-12 |
| 47896 | SUPPL | 2017-04-07 |
| 1153 | SUPPL | 2015-07-10 |
| 33672 | SUPPL | 2015-07-09 |
| 16130 | SUPPL | 2007-10-04 |
| 16129 | SUPPL | 2005-03-30 |
| 1152 | SUPPL | 2004-12-29 |
| 1151 | SUPPL | 2004-03-10 |
| 20171 | SUPPL | 2003-08-05 |
| 16128 | SUPPL | 2002-12-23 |
| 1150 | SUPPL | 2002-12-23 |
| 40833 | SUPPL | 1998-05-11 |