FdaApplication
NDA 019546
Identifiers
- fda_app_no: NDA019546
Properties
| Property | Value |
|---|---|
| applicant_name | SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE |
| application_type | NDA |
| approval_date | 1990-12-20 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DYNACIRC | ISRADIPINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
| DYNACIRC | ISRADIPINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
2 products