FdaApplication
ANDA 218870
Identifiers
- fda_app_no: ANDA218870
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2025-10-02 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 5MG/ML | INJECTABLE;INJECTION |
1 product