药品注册申请号：207961
申请类型：ANDA (仿制药申请)
申请人：HETERO LABS LTD III
申请人全名：HETERO LABS LTD UNIT III
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 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE No No AB;AB 2020/05/06 2020/05/06 Prescription
002 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE No No AB;AB 2020/05/06 Prescription
003 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE No No AB;AB 2024/08/13 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
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/08/13 ORIG-2（原始申请） Approval STANDARD
2020/05/06 ORIG-1（原始申请） Approval STANDARD
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:DABIGATRAN ETEXILATE MESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 75MG BASE 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
022512 001 NDA PRADAXA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription Yes No AB 2010/10/19 BOEHRINGER INGELHEIM
208040 001 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2020/03/11 ALKEM LABS LTD
207961 001 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2020/05/06 HETERO LABS LTD III
208070 001 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2023/12/15 APOTEX
213879 001 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2024/05/22 MSN
215233 001 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2024/06/14 ALEMBIC
活性成分:DABIGATRAN ETEXILATE MESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 75MG BASE 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
022512 001 NDA PRADAXA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription Yes No AB 2010/10/19 BOEHRINGER INGELHEIM
208040 001 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2020/03/11 ALKEM LABS LTD
207961 001 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2020/05/06 HETERO LABS LTD III
208070 001 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2023/12/15 APOTEX
213879 001 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2024/05/22 MSN
215233 001 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2024/06/14 ALEMBIC
活性成分:DABIGATRAN ETEXILATE MESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 150MG BASE 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
022512 002 NDA PRADAXA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription Yes Yes AB 2010/10/19 BOEHRINGER INGELHEIM
208040 002 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2020/03/11 ALKEM LABS LTD
207961 002 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2020/05/06 HETERO LABS LTD III
208070 003 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2023/12/15 APOTEX
213879 002 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2024/05/22 MSN
215233 002 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2024/06/14 ALEMBIC
活性成分:DABIGATRAN ETEXILATE MESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 150MG BASE 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
022512 002 NDA PRADAXA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription Yes Yes AB 2010/10/19 BOEHRINGER INGELHEIM
208040 002 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2020/03/11 ALKEM LABS LTD
207961 002 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2020/05/06 HETERO LABS LTD III
208070 003 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2023/12/15 APOTEX
213879 002 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2024/05/22 MSN
215233 002 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2024/06/14 ALEMBIC
活性成分:DABIGATRAN ETEXILATE MESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 110MG BASE 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
022512 003 NDA PRADAXA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription Yes No AB 2015/11/20 BOEHRINGER INGELHEIM
208070 002 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription No No AB 2023/12/15 APOTEX
213879 003 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription No No AB 2024/08/12 MSN
215233 003 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription No No AB 2024/08/12 ALEMBIC
207961 003 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription No No AB 2024/08/13 HETERO LABS LTD III
208040 003 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription No No AB 2024/09/11 ALKEM LABS LTD
活性成分:DABIGATRAN ETEXILATE MESYLATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 110MG BASE 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
022512 003 NDA PRADAXA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription Yes No AB 2015/11/20 BOEHRINGER INGELHEIM
208070 002 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription No No AB 2023/12/15 APOTEX
213879 003 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription No No AB 2024/08/12 MSN
215233 003 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription No No AB 2024/08/12 ALEMBIC
207961 003 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription No No AB 2024/08/13 HETERO LABS LTD III
208040 003 ANDA DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Prescription No No AB 2024/09/11 ALKEM LABS LTD
更多信息
药品NDC数据与药品包装、标签说明书
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