Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 219332
Company: ASCENT PHARMS INC
Company: ASCENT PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | AB | No | No |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | AB | 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
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 210301 | ALEMBIC |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 217810 | APOTEX |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 219332 | ASCENT PHARMS INC |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 208544 | AUROBINDO PHARMA LTD |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 218107 | BIOCON PHARMA |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 208534 | DR REDDYS |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 208555 | LUPIN LTD |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 213114 | MACLEODS PHARMS LTD |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 208546 | MSN |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 218445 | REGCON HOLDINGS |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 218117 | SCIEGEN PHARMS |
| RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 208557 | TARO |
| XARELTO | RIVAROXABAN | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 022406 | JANSSEN PHARMS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 216995 | AIPING PHARM INC |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 210301 | ALEMBIC |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208579 | APOTEX |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 219332 | ASCENT PHARMS INC |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208544 | AUROBINDO PHARMA LTD |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 218107 | BIOCON PHARMA |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208220 | BRECKENRIDGE |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208534 | DR REDDYS |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208555 | LUPIN LTD |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 213114 | MACLEODS PHARMS LTD |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 218445 | REGCON HOLDINGS |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 218117 | SCIEGEN PHARMS |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 213348 | SUNSHINE |
| RIVAROXABAN | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | No | AB | 208557 | TARO |
| XARELTO | RIVAROXABAN | 10MG | TABLET;ORAL | Prescription | Yes | AB | 022406 | JANSSEN PHARMS |
TABLET;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 216995 | AIPING PHARM INC |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 210301 | ALEMBIC |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 208579 | APOTEX |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 219332 | ASCENT PHARMS INC |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 208544 | AUROBINDO PHARMA LTD |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 218107 | BIOCON PHARMA |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 208220 | BRECKENRIDGE |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 208534 | DR REDDYS |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 208555 | LUPIN LTD |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 213114 | MACLEODS PHARMS LTD |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 218445 | REGCON HOLDINGS |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 218117 | SCIEGEN PHARMS |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 213348 | SUNSHINE |
| RIVAROXABAN | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | No | AB | 208557 | TARO |
| XARELTO | RIVAROXABAN | 15MG | TABLET;ORAL | Prescription | Yes | AB | 022406 | JANSSEN PHARMS |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 216995 | AIPING PHARM INC |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 210301 | ALEMBIC |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 208579 | APOTEX |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 219332 | ASCENT PHARMS INC |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 208544 | AUROBINDO PHARMA LTD |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 218107 | BIOCON PHARMA |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 208220 | BRECKENRIDGE |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 208534 | DR REDDYS |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 208555 | LUPIN LTD |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 213114 | MACLEODS PHARMS LTD |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 218445 | REGCON HOLDINGS |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 218117 | SCIEGEN PHARMS |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 213348 | SUNSHINE |
| RIVAROXABAN | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | No | AB | 208557 | TARO |
| XARELTO | RIVAROXABAN | 20MG | TABLET;ORAL | Prescription | Yes | AB | 022406 | JANSSEN PHARMS |