Application 210016
- Type
- ANDA
- Sponsor
- GE HEALTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLARISCAN | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 3.769GM/10ML (376.9MG/ML) | No | No |
| 002 | CLARISCAN | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 5.6535GM/15ML (376.9MG/ML) | No | No |
| 003 | CLARISCAN | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 7.538GM/20ML (376.9MG/ML) | No | No |
| 004 | CLARISCAN | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 37.69GM/100ML (376.9MG/ML) | No | No |
| 005 | CLARISCAN | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 1.8845GM/5ML (376.9MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0407-2943 | CLARISCAN | gadoterate meglumine | GE Healthcare | ANDA | Current |
| 0407-2943 | CLARISCAN | gadoterate meglumine | GE Healthcare | ANDA | Current |
| 0407-2943 | CLARISCAN | gadoterate meglumine | GE Healthcare | ANDA | Current |
| 0407-2943 | CLARISCAN | gadoterate meglumine | GE Healthcare | ANDA | Current |
| 0407-2943 | CLARISCAN | gadoterate meglumine | GE Healthcare | ANDA | Current |
| 0407-2943 | CLARISCAN | gadoterate meglumine | GE Healthcare | ANDA | Current |
| 0407-2943 | CLARISCAN | gadoterate meglumine | GE Healthcare | ANDA | Current |
| 0407-2943 | CLARISCAN | gadoterate meglumine | GE Healthcare | ANDA | Current |
| 0407-2943 | CLARISCAN | gadoterate meglumine | GE Healthcare | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61136 | ORIG | 2019-12-04 |