Application 020608
- Type
- NDA
- Sponsor
- GE HEALTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMNIPAQUE 240 | IOHEXOL | SOLUTION;INJECTION, ORAL, RECTAL | 51.8% | No | No |
| 002 | OMNIPAQUE 300 | IOHEXOL | SOLUTION;INJECTION, ORAL, RECTAL | 64.7% | No | No |
| 003 | OMNIPAQUE 350 | IOHEXOL | SOLUTION;INJECTION, ORAL | 75.5% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0407-1413 | Omnipaque | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | Omnipaque | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | Omnipaque | Iohexol | GE Healthcare | NDA | Current |
| 0407-1413 | Omnipaque | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | Omnipaque | Iohexol | GE Healthcare | NDA | Current |
| 0407-1413 | Omnipaque | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | Omnipaque | Iohexol | GE Healthcare | NDA | Current |
| 0407-1413 | Omnipaque | Iohexol | GE Healthcare | NDA | Current |
| 0407-1413 | Omnipaque | Iohexol | GE Healthcare | 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 | NDA | Current |
| 0407-1413 | Omnipaque | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1413 | Omnipaque | Iohexol | GE Healthcare | 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 | 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 | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare | 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 | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare Inc. | NDA | Current |
| 0407-1414 | Omnipaque | Iohexol | GE Healthcare Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79848 | SUPPL | 2024-10-09 |
| 79843 | SUPPL | 2024-10-09 |
| 74083 | SUPPL | 2023-04-27 |
| 74074 | SUPPL | 2023-04-27 |
| 70269 | SUPPL | 2022-02-25 |
| 70220 | SUPPL | 2022-02-22 |
| 50403 | SUPPL | 2017-11-14 |
| 50384 | SUPPL | 2017-11-13 |
| 47965 | SUPPL | 2017-04-12 |
| 47898 | SUPPL | 2017-04-07 |
| 47897 | SUPPL | 2017-04-07 |
| 46523 | SUPPL | 2016-12-23 |
| 46498 | SUPPL | 2016-12-21 |
| 25319 | SUPPL | 2015-07-10 |
| 12842 | SUPPL | 2015-07-09 |
| 2869 | SUPPL | 2007-10-04 |
| 25317 | SUPPL | 2004-03-10 |
| 25318 | SUPPL | 2004-03-03 |