FdaApplication
ANDA 089513
Identifiers
- fda_app_no: ANDA089513
Properties
| Property | Value |
|---|---|
| applicant_name | ROXANE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 1989-04-25 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 500MG;60MG | TABLET;ORAL |
1 product