FdaApplication
NDA 021305
Identifiers
- fda_app_no: NDA021305
Properties
| Property | Value |
|---|---|
| applicant_name | JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA |
| application_type | NDA |
| approval_date | 2003-01-24 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HICON | SODIUM IODIDE I-131 | 1-250mCi/0.25ML | SOLUTION;ORAL |
| HICON | SODIUM IODIDE I-131 | 250-1000mCi | SOLUTION;ORAL |
| HICON | SODIUM IODIDE I-131 | 1-500mCi/0.5ML | SOLUTION;ORAL |
| HICON | SODIUM IODIDE I-131 | 1-1000mCi/ML | SOLUTION;ORAL |
| SODIUM IODIDE I 131 | SODIUM IODIDE I-131 | 2-200mCi | CAPSULE;ORAL |
| SODIUM IODIDE I 131 | SODIUM IODIDE I-131 | 0.009-0.1mCi | CAPSULE;ORAL |
6 products