药品注册申请号：208557
申请类型：ANDA (仿制药申请)
申请人：TARO
申请人全名：TARO PHARMACEUTICAL INDUSTRIES LTD
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG No No AB;AB 2025/03/03 2025/03/03 Prescription
002 RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG No No AB;AB 2025/10/07 Prescription
003 RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG No No AB;AB 2025/10/07 Prescription
004 RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG No No AB;AB 2025/10/07 Prescription
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/10/07 ORIG-2（原始申请） Approval STANDARD
2025/03/03 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
无
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
无
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
>>>活性成分:RIVAROXABAN; 剂型/给药途径:TABLET;ORAL; 规格:2.5MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
022406 004 NDA XARELTO RIVAROXABAN TABLET;ORAL 2.5MG Prescription Yes No AB 2018/10/11 JANSSEN PHARMS
208555 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/03/03 LUPIN LTD
208557 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/03/03 TARO
208544 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/04/10 AUROBINDO PHARMA LTD
217810 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/02 APOTEX
218107 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/14 BIOCON PHARMA
219332 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/14 ASCENT PHARMS INC
208534 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/14 DR REDDYS
210301 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/14 ALEMBIC
213114 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/14 MACLEODS PHARMS LTD
218117 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/07/31 SCIEGEN PHARMS INC
218445 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/08/11 REGCON HOLDINGS
208546 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/10/24 MSN
>>>活性成分:RIVAROXABAN; 剂型/给药途径:TABLET;ORAL; 规格:2.5MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
022406 004 NDA XARELTO RIVAROXABAN TABLET;ORAL 2.5MG Prescription Yes No AB 2018/10/11 JANSSEN PHARMS
208555 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/03/03 LUPIN LTD
208557 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/03/03 TARO
208544 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/04/10 AUROBINDO PHARMA LTD
217810 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/02 APOTEX
218107 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/14 BIOCON PHARMA
219332 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/14 ASCENT PHARMS INC
208534 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/14 DR REDDYS
210301 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/14 ALEMBIC
213114 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/05/14 MACLEODS PHARMS LTD
218117 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/07/31 SCIEGEN PHARMS INC
218445 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/08/11 REGCON HOLDINGS
208546 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 2.5MG Prescription No No AB 2025/10/24 MSN
>>>活性成分:RIVAROXABAN; 剂型/给药途径:TABLET;ORAL; 规格:10MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
208579 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB -- APOTEX
022406 001 NDA XARELTO RIVAROXABAN TABLET;ORAL 10MG Prescription Yes No AB 2011/07/01 JANSSEN PHARMS
208555 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 LUPIN LTD
208534 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 DR REDDYS
208543 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Discontinued No No AB 2025/05/14 INVAGEN PHARMS
210301 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 ALEMBIC
213114 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 MACLEODS PHARMS LTD
213348 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 SUNSHINE
216995 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 AIPING PHARM INC
218107 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 BIOCON PHARMA
219332 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 ASCENT PHARMS INC
208544 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/15 AUROBINDO PHARMA LTD
208220 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/15 BRECKENRIDGE
218117 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/07/31 SCIEGEN PHARMS INC
218445 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/08/11 REGCON HOLDINGS
208557 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/10/07 TARO
208546 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Discontinued No No AB 2025/10/24 MSN
>>>活性成分:RIVAROXABAN; 剂型/给药途径:TABLET;ORAL; 规格:10MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
208579 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB -- APOTEX
022406 001 NDA XARELTO RIVAROXABAN TABLET;ORAL 10MG Prescription Yes No AB 2011/07/01 JANSSEN PHARMS
208555 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 LUPIN LTD
208534 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 DR REDDYS
208543 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Discontinued No No AB 2025/05/14 INVAGEN PHARMS
210301 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 ALEMBIC
213114 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 MACLEODS PHARMS LTD
213348 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 SUNSHINE
216995 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 AIPING PHARM INC
218107 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 BIOCON PHARMA
219332 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/14 ASCENT PHARMS INC
208544 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/15 AUROBINDO PHARMA LTD
208220 001 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/05/15 BRECKENRIDGE
218117 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/07/31 SCIEGEN PHARMS INC
218445 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/08/11 REGCON HOLDINGS
208557 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Prescription No No AB 2025/10/07 TARO
208546 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG Discontinued No No AB 2025/10/24 MSN
>>>活性成分:RIVAROXABAN; 剂型/给药途径:TABLET;ORAL; 规格:15MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
208579 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB -- APOTEX
022406 002 NDA XARELTO RIVAROXABAN TABLET;ORAL 15MG Prescription Yes No AB 2011/11/04 JANSSEN PHARMS
208555 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 LUPIN LTD
208534 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 DR REDDYS
208543 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Discontinued No No AB 2025/05/14 INVAGEN PHARMS
210301 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 ALEMBIC
213114 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 MACLEODS PHARMS LTD
213348 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 SUNSHINE
216995 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 AIPING PHARM INC
218107 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 BIOCON PHARMA
219332 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 ASCENT PHARMS INC
208544 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/15 AUROBINDO PHARMA LTD
208220 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/15 BRECKENRIDGE
218117 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/07/31 SCIEGEN PHARMS INC
218445 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/08/11 REGCON HOLDINGS
208557 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/10/07 TARO
208546 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Discontinued No No AB 2025/10/24 MSN
>>>活性成分:RIVAROXABAN; 剂型/给药途径:TABLET;ORAL; 规格:15MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
208579 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB -- APOTEX
022406 002 NDA XARELTO RIVAROXABAN TABLET;ORAL 15MG Prescription Yes No AB 2011/11/04 JANSSEN PHARMS
208555 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 LUPIN LTD
208534 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 DR REDDYS
208543 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Discontinued No No AB 2025/05/14 INVAGEN PHARMS
210301 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 ALEMBIC
213114 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 MACLEODS PHARMS LTD
213348 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 SUNSHINE
216995 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 AIPING PHARM INC
218107 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 BIOCON PHARMA
219332 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/14 ASCENT PHARMS INC
208544 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/15 AUROBINDO PHARMA LTD
208220 002 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/05/15 BRECKENRIDGE
218117 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/07/31 SCIEGEN PHARMS INC
218445 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/08/11 REGCON HOLDINGS
208557 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Prescription No No AB 2025/10/07 TARO
208546 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG Discontinued No No AB 2025/10/24 MSN
>>>活性成分:RIVAROXABAN; 剂型/给药途径:TABLET;ORAL; 规格:20MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
208579 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB -- APOTEX
022406 003 NDA XARELTO RIVAROXABAN TABLET;ORAL 20MG Prescription Yes Yes AB 2011/11/04 JANSSEN PHARMS
208555 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 LUPIN LTD
208534 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 DR REDDYS
208543 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Discontinued No No AB 2025/05/14 INVAGEN PHARMS
210301 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 ALEMBIC
213114 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 MACLEODS PHARMS LTD
213348 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 SUNSHINE
216995 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 AIPING PHARM INC
218107 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 BIOCON PHARMA
219332 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 ASCENT PHARMS INC
208544 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/15 AUROBINDO PHARMA LTD
208220 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/15 BRECKENRIDGE
218117 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/07/31 SCIEGEN PHARMS INC
218445 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/08/11 REGCON HOLDINGS
208557 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/10/07 TARO
208546 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Discontinued No No AB 2025/10/24 MSN
>>>活性成分:RIVAROXABAN; 剂型/给药途径:TABLET;ORAL; 规格:20MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
208579 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB -- APOTEX
022406 003 NDA XARELTO RIVAROXABAN TABLET;ORAL 20MG Prescription Yes Yes AB 2011/11/04 JANSSEN PHARMS
208555 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 LUPIN LTD
208534 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 DR REDDYS
208543 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Discontinued No No AB 2025/05/14 INVAGEN PHARMS
210301 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 ALEMBIC
213114 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 MACLEODS PHARMS LTD
213348 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 SUNSHINE
216995 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 AIPING PHARM INC
218107 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 BIOCON PHARMA
219332 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/14 ASCENT PHARMS INC
208544 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/15 AUROBINDO PHARMA LTD
208220 003 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/05/15 BRECKENRIDGE
218117 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/07/31 SCIEGEN PHARMS INC
218445 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/08/11 REGCON HOLDINGS
208557 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Prescription No No AB 2025/10/07 TARO
208546 004 ANDA RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG Discontinued No No AB 2025/10/24 MSN
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