FdaApplication
ANDA 216597
Identifiers
- fda_app_no: ANDA216597
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2023-02-15 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 2GM/50ML (40MG/ML) | INJECTABLE;INJECTION |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 4GM/100ML (40MG/ML) | INJECTABLE;INJECTION |
2 products