FdaApplication
NDA 050686
Identifiers
- fda_app_no: NDA050686
Properties
| Property | Value |
|---|---|
| applicant_name | BURKE THERAPEUTICS LLC |
| application_type | NDA |
| approval_date | 1995-12-20 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CEDAX | CEFTIBUTEN DIHYDRATE | EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL |
| CEDAX | CEFTIBUTEN DIHYDRATE | EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL |
2 products