FdaApplication
NDA 011265
Identifiers
- fda_app_no: NDA011265
Properties
| Property | Value |
|---|---|
| applicant_name | ANI PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1984-04-02 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL |
1 product