FdaApplication
ANDA 084659
Identifiers
- fda_app_no: ANDA084659
Properties
| Property | Value |
|---|---|
| applicant_name | ROXANE LABORATORIES INC |
| application_type | ANDA |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL |
1 product