Application 021305
- Type
- NDA
- Sponsor
- JUBILANT DRAXIMAGE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | HICON | SODIUM IODIDE I-131 | SOLUTION;ORAL | 1-250mCi/0.25ML | No | No |
| 003 | HICON | SODIUM IODIDE I-131 | SOLUTION;ORAL | 1-500mCi/0.5ML | No | No |
| 004 | SODIUM IODIDE I 131 | SODIUM IODIDE I-131 | CAPSULE;ORAL | 2-200mCi | No | No |
| 005 | HICON | SODIUM IODIDE I-131 | SOLUTION;ORAL | 1-1000mCi/ML | No | No |
| 006 | SODIUM IODIDE I 131 | SODIUM IODIDE I-131 | CAPSULE;ORAL | 0.009-0.1mCi | Yes | No |
| 007 | HICON | SODIUM IODIDE I-131 | SOLUTION;ORAL | 250-1000mCi | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65174-461 | Sodium Iodide I 131 Diagnostic | Sodium Iodide I 131 | Jubilant DraxImage Inc., dba Jubilant Radiopharma | NDA | Current |
| 65174-461 | Sodium Iodide I 131 Diagnostic | Sodium Iodide I 131 | Jubilant DraxImage Inc. | NDA | Current |
| 65174-461 | Sodium Iodide I 131 Diagnostic | Sodium Iodide I 131 | Jubilant DraxImage Inc. | NDA | Current |
| 65174-461 | Sodium Iodide I 131 Diagnostic | Sodium Iodide I 131 | Jubilant DraxImage Inc. | NDA | Current |
| 65174-461 | Sodium Iodide I 131 Diagnostic | Sodium Iodide I 131 | Jubilant DraxImage Inc. | NDA | Current |
| 65174-880 | HICON | Sodium Iodide I 131 | Jubilant DraxImage Inc., dba Jubilant Radiopharma | NDA | Current |
| 65174-880 | HICON | Sodium Iodide I 131 | Jubilant DraxImage Inc., dba Jubilant Radiopharma | NDA | Current |
| 65174-880 | HICON | Sodium Iodide I 131 | Jubilant DraxImage Inc., dba Jubilant Radiopharma | NDA | Current |
| 65174-880 | HICON | Sodium Iodide I 131 | Jubilant DraxImage Inc. | NDA | Current |
| 65174-880 | HICON | Sodium Iodide I 131 | Jubilant DraxImage Inc., dba Jubilant Radiopharma | NDA | Current |