FdaApplication
ANDA 218469
Identifiers
- fda_app_no: ANDA218469
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2025-08-08 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SODIUM ACETATE | SODIUM ACETATE | 40MEQ/20ML (2MEQ/ML) | SOLUTION;INTRAVENOUS |
| SODIUM ACETATE | SODIUM ACETATE | 200MEQ/100ML (2MEQ/ML) | SOLUTION;INTRAVENOUS |
| SODIUM ACETATE | SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML) | SOLUTION;INTRAVENOUS |
3 products