FdaApplication
NDA 008381
Identifiers
- fda_app_no: NDA008381
Properties
| Property | Value |
|---|---|
| applicant_name | ANI PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1984-04-18 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE PLAIN | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL |
| PROMETHAZINE HYDROCHLORIDE PLAIN | PROMETHAZINE HYDROCHLORIDE | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL |
2 products