Application 215061
- Type
- ANDA
- Sponsor
- HENGRUI PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 1.20944GM/2ML (604.72MG/ML) | No | No |
| 002 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 4.5354GM/7.5ML (604.72MG/ML) | No | No |
| 003 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 6.0472GM/10ML (604.72MG/ML) | No | No |
| 004 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 9.0708GM/15ML (604.72MG/ML) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72940 | ORIG | 2022-12-20 |