FdaApplication
ANDA 217523
Identifiers
- fda_app_no: ANDA217523
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2026-01-13 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION;INTRAVENOUS |
1 product