FdaApplication
ANDA 216604
Identifiers
- fda_app_no: ANDA216604
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2023-05-15 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE;INJECTION |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE;INJECTION |
2 products