Application 203968
- Type
- ANDA
- Sponsor
- JUBILANT DRAXIMAGE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM FLUORIDE F-18 | SODIUM FLUORIDE F-18 | INJECTABLE;INTRAVENOUS | 10-200mCi/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60055-623 | Sodium Fluoride F 18 | Sodium Fluoride F 18 | JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA JUBILANT RADIOPHARMA | ANDA | Current |
| 60055-623 | Sodium Fluoride F 18 | Sodium Fluoride F 18 | JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA JUBILANT RADIOPHARMA | ANDA | Current |
| 60055-623 | Sodium Fluoride F 18 | Sodium Fluoride F 18 | JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA TRIAD ISOTOPES | ANDA | Current |
| 60055-623 | Sodium Fluoride F 18 | Sodium Fluoride F 18 | JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA TRIAD ISOTOPES | ANDA | Current |
| 60055-623 | Sodium Fluoride F 18 | Sodium Fluoride F 18 | JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA JUBILANT RADIOPHARMA | ANDA | Current |