FdaApplication
ANDA 089775
Identifiers
- fda_app_no: ANDA089775
Properties
| Property | Value |
|---|---|
| applicant_name | ROXANE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 1989-01-12 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROXICET 5/500 | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 500MG;5MG | TABLET;ORAL |
1 product