FdaApplication
NDA 050527
Identifiers
- fda_app_no: NDA050527
Properties
| Property | Value |
|---|---|
| applicant_name | WARNER CHILCOTT INC |
| application_type | NDA |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DURICEF | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL |
| DURICEF | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL |
| DURICEF | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL |
3 products