FdaApplication
ANDA 216603
Identifiers
- fda_app_no: ANDA216603
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2022-12-13 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION |
2 products