FdaApplication
ANDA 219099
Identifiers
- fda_app_no: ANDA219099
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2026-06-02 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROMIDEPSIN | ROMIDEPSIN | 27.5MG/5.5ML (5MG/ML) | SOLUTION;INTRAVENOUS |
1 product