FdaApplication
ANDA 074476
Identifiers
- fda_app_no: ANDA074476
Properties
| Property | Value |
|---|---|
| applicant_name | ROXANE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 1995-08-18 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL |
1 product