FdaApplication
ANDA 217949
Identifiers
- fda_app_no: ANDA217949
Properties
| Property | Value |
|---|---|
| applicant_name | MACLEODS PHARMACEUTICALS LTD |
| application_type | ANDA |
| approval_date | 2025-09-23 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL |
3 products