FdaApplication
NDA 208418
Identifiers
- fda_app_no: NDA208418
Properties
| Property | Value |
|---|---|
| applicant_name | FRESENIUS KABI USA LLC |
| application_type | NDA |
| approval_date | 2017-06-15 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 1GM/10ML (100MG/ML) | SOLUTION;INTRAVENOUS |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 10GM/100ML (100MG/ML) | SOLUTION;INTRAVENOUS |
| CALCIUM GLUCONATE | CALCIUM GLUCONATE | 5GM/50ML (100MG/ML) | SOLUTION;INTRAVENOUS |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 2GM/100ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | 1GM/50ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS |
5 products