Application 203920
- Type
- ANDA
- Sponsor
- JUBILANT DRAXIMAGE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60055-334 | Fludeoxyglucose F 18 | Fludeoxyglucose F-18 | JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA JUBILANT RADIOPHARMA | ANDA | Current |
| 60055-334 | Fludeoxyglucose F 18 | Fludeoxyglucose F-18 | JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA JUBILANT RADIOPHARMA | ANDA | Current |
| 60055-334 | Fludeoxyglucose F 18 | Fludeoxyglucose F-18 | JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA TRIAD ISOTOPES | ANDA | Current |
| 60055-334 | Fludeoxyglucose F 18 | Fludeoxyglucose F-18 | JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA TRIAD ISOTOPES | ANDA | Current |
| 60055-334 | Fludeoxyglucose F 18 | Fludeoxyglucose F-18 | Jubilant DraxImage Inc., dba Jubilant Radiopharma | ANDA | Current |
| 60055-334 | Fludeoxyglucose F 18 | Fludeoxyglucose F-18 | JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA JUBILANT RADIOPHARMA | ANDA | Current |
| 60055-334 | Fludeoxyglucose F 18 | Fludeoxyglucose F-18 | JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA JUBILANT RADIOPHARMA | ANDA | Current |