FdaApplication
NDA 019425
Identifiers
- fda_app_no: NDA019425
Properties
| Property | Value |
|---|---|
| applicant_name | SEBELA IRELAND LTD |
| application_type | NDA |
| approval_date | 1985-12-31 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TRANDATE | LABETALOL HYDROCHLORIDE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
1 product