FdaApplication
NDA 019594
Identifiers
- fda_app_no: NDA019594
Properties
| Property | Value |
|---|---|
| applicant_name | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC |
| application_type | NDA |
| approval_date | 1987-12-31 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ACTIGALL | URSODIOL | 300MG | CAPSULE;ORAL |
| ACTIGALL | URSODIOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
2 products