Application 017630
- Type
- NDA
- Sponsor
- GE HEALTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | CAPSULE;ORAL | 100uCi | No | No |
| 002 | SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | SOLUTION;ORAL | 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 003 | SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | CAPSULE;ORAL | 200uCi | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 13871 | SUPPL | 2005-06-21 |