Application 203709
- Type
- ANDA
- Sponsor
- WI MEDCL CYCLOTRON
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-500mCi/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 44338-001 | Fludeoxyglucose F18 | Fludeoxyglucose F-18 | Wisconsin Medical Cyclotron LLC | ANDA | Current |
| 44338-001 | Fludeoxyglucose F18 | Fludeoxyglucose F-18 | Wisconsin Medical Cyclotron LLC | ANDA | Current |
| 81365-001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | Wisconsin Medical Radiopharmacy, LLC | ANDA | Current |
| 81365-001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | Wisconsin Medical Radiopharmacy, LLC | ANDA | Current |