FdaApplication
NDA 050685
Identifiers
- fda_app_no: NDA050685
Properties
| Property | Value |
|---|---|
| applicant_name | BURKE THERAPEUTICS LLC |
| application_type | NDA |
| approval_date | 1995-12-20 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CEDAX | CEFTIBUTEN DIHYDRATE | EQ 400MG BASE | CAPSULE;ORAL |
1 product