Application 217174
- Type
- ANDA
- Sponsor
- AMNEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 1GM/50ML (20MG/ML) | No | Yes |
| 002 | CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 2GM/100ML (20MG/ML) | No | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75957 | ORIG | 2023-10-27 |