FdaApplication
NDA 012142
Identifiers
- fda_app_no: NDA012142
Properties
| Property | Value |
|---|---|
| applicant_name | BAXTER HEALTHCARE CORP |
| application_type | NDA |
| approval_date | 1982-08-30 |
Products (10)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CYTOXAN | CYCLOPHOSPHAMIDE | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| CYTOXAN | CYCLOPHOSPHAMIDE | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| CYTOXAN (LYOPHILIZED) | CYCLOPHOSPHAMIDE | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| LYOPHILIZED CYTOXAN | CYCLOPHOSPHAMIDE | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| LYOPHILIZED CYTOXAN | CYCLOPHOSPHAMIDE | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
10 products