FdaApplication
ANDA 218586
Identifiers
- fda_app_no: ANDA218586
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2025-09-02 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| RISPERIDONE | RISPERIDONE | 50MG/VIAL | POWDER;INTRAMUSCULAR |
| RISPERIDONE | RISPERIDONE | 25MG/VIAL | POWDER;INTRAMUSCULAR |
| RISPERIDONE | RISPERIDONE | 37.5MG/VIAL | POWDER;INTRAMUSCULAR |
| RISPERIDONE | RISPERIDONE | 12.5MG/VIAL | POWDER;INTRAMUSCULAR |
4 products