FdaApplication
ANDA 088763
Identifiers
- fda_app_no: ANDA088763
Properties
| Property | Value |
|---|---|
| applicant_name | ACTAVIS MID ATLANTIC LLC |
| application_type | ANDA |
| approval_date | 1984-10-31 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL |
1 product