Application 209166
- Type
- ANDA
- Sponsor
- INTL ISOTOPES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM IODIDE I 131 | SODIUM IODIDE I-131 | SOLUTION;ORAL | 250-1000mCi | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69208-000 | Sodium Iodide I-131 | Sodium Iodide I-131 | International Isotopes Inc | ANDA | Current |
| 69208-000 | Sodium Iodide I-131 | Sodium Iodide I-131 | International Isotopes Inc | ANDA | Current |
| 69208-000 | Sodium Iodide I-131 | Sodium Iodide I-131 | International Isotopes Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 62173 | ORIG | 2020-03-17 |