FdaApplication
NDA 213645
Identifiers
- fda_app_no: NDA213645
Properties
| Property | Value |
|---|---|
| applicant_name | BAXTER HEALTHCARE CORP |
| application_type | NDA |
| approval_date | 2022-01-25 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | 700MG/100ML (7MG/ML) | SOLUTION;INTRAVENOUS |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | 350MG/50ML (7MG/ML) | SOLUTION;INTRAVENOUS |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | 500MG/50ML (10MG/ML) | SOLUTION;INTRAVENOUS |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS |
| DAPZURA RT | DAPTOMYCIN | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAVENOUS |
5 products