FdaApplication
ANDA 218445
Identifiers
- fda_app_no: ANDA218445
Properties
| Property | Value |
|---|---|
| applicant_name | REGCON HOLDINGS LLC |
| application_type | ANDA |
| approval_date | 2025-08-11 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL |
4 products