Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218107
Company: BIOCON PHARMA
Company: BIOCON PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | BX | No | No |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | BX | No | No |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | BX | No | No |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | BX | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/14/2025 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
RIVAROXABAN
There are no Therapeutic Equivalents.