Application 215982
- Type
- ANDA
- Sponsor
- JIANGSU HENGRUI MED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 37.69GM/100ML (376.9MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65219-088 | Gadoterate Meglumine | gadoterate meglumine | Fresenius Kabi USA, LLC | ANDA | Current |