FdaApplication
NDA 018716
Identifiers
- fda_app_no: NDA018716
Properties
| Property | Value |
|---|---|
| applicant_name | ALVOGEN INC |
| application_type | NDA |
| approval_date | 1984-08-01 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TRANDATE | LABETALOL HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| TRANDATE | LABETALOL HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| TRANDATE | LABETALOL HYDROCHLORIDE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| TRANDATE | LABETALOL HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
4 products