FdaApplication
NDA 016792
Identifiers
- fda_app_no: NDA016792
Properties
| Property | Value |
|---|---|
| applicant_name | TEVA WOMENS HEALTH INC |
| application_type | NDA |
| approval_date | 1982-09-15 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SURMONTIL | TRIMIPRAMINE MALEATE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
| SURMONTIL | TRIMIPRAMINE MALEATE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
| SURMONTIL | TRIMIPRAMINE MALEATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
3 products