FdaApplication
ANDA 087003
Identifiers
- fda_app_no: ANDA087003
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA PHARMS |
| application_type | ANDA |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROXICET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
1 product