FdaApplication
ANDA 207743
Identifiers
- fda_app_no: ANDA207743
Properties
| Property | Value |
|---|---|
| applicant_name | ZYDUS PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2017-09-19 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL |
3 products