FdaApplication
ANDA 089351
Identifiers
- fda_app_no: ANDA089351
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA PHARMS |
| application_type | ANDA |
| approval_date | 1986-12-03 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROXICET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL |
1 product