药品注册申请号：076684
申请类型：ANDA (仿制药申请)
申请人：AMPHASTAR PHARM
申请人全名：AMPHASTAR PHARMACEUTICAL INC
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 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 30MG/0.3ML (100MG/ML) No No AP 2011/09/19 2011/09/19 Prescription
002 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 40MG/0.4ML (100MG/ML) No No AP 2011/09/19 Prescription
003 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 60MG/0.6ML (100MG/ML) No No AP 2011/09/19 Prescription
004 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 80MG/0.8ML (100MG/ML) No No AP 2011/09/19 Prescription
005 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 100MG/ML (100MG/ML) No No AP 2011/09/19 Prescription
006 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 120MG/0.8ML (150MG/ML) No No AP 2011/09/19 Prescription
007 ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 150MG/ML (150MG/ML) No No AP 2011/09/19 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
2022/11/15 SUPPL-16（补充） Approval Labeling STANDARD
2020/10/30 SUPPL-11（补充） Approval Labeling STANDARD
2014/10/24 SUPPL-3（补充） Approval Manufacturing (CMC)
2012/08/24 SUPPL-4（补充） Approval Labeling STANDARD
2011/09/19 ORIG-1（原始申请） Approval
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:ENOXAPARIN SODIUM 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:30MG/0.3ML (100MG/ML) 治疗等效代码:AP
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
020164 001 NDA LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 30MG/0.3ML (100MG/ML) Prescription Yes No AP 1993/03/29 SANOFI AVENTIS US
077857 002 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 30MG/0.3ML (100MG/ML) Prescription No No AP 2010/07/23 SANDOZ
076684 001 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 30MG/0.3ML (100MG/ML) Prescription No No AP 2011/09/19 AMPHASTAR PHARM
076726 001 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 30MG/0.3ML (100MG/ML) Prescription No No AP 2014/06/23 ZYDUS PHARMS
078990 001 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 30MG/0.3ML (100MG/ML) Prescription No No AP 2018/09/28 GLAND
206834 001 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 30MG/0.3ML (100MG/ML) Prescription No No AP 2019/11/29 NANJING KING-FRIEND
205660 001 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 30MG/0.3ML (100MG/ML) Prescription No No AP 2023/03/15 SHENZHEN TECHDOW
214646 001 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 30MG/0.3ML (100MG/ML) Prescription No No AP 2023/06/06 BE PHARMS
活性成分:ENOXAPARIN SODIUM 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:40MG/0.4ML (100MG/ML) 治疗等效代码:AP
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
020164 002 NDA LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 40MG/0.4ML (100MG/ML) Prescription Yes No AP 1998/01/30 SANOFI AVENTIS US
077857 003 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 40MG/0.4ML (100MG/ML) Prescription No No AP 2010/07/23 SANDOZ
076684 002 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 40MG/0.4ML (100MG/ML) Prescription No No AP 2011/09/19 AMPHASTAR PHARM
076726 002 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 40MG/0.4ML (100MG/ML) Prescription No No AP 2014/06/23 ZYDUS PHARMS
078990 002 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 40MG/0.4ML (100MG/ML) Prescription No No AP 2018/09/28 GLAND
206834 002 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 40MG/0.4ML (100MG/ML) Prescription No No AP 2019/11/29 NANJING KING-FRIEND
205660 002 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 40MG/0.4ML (100MG/ML) Prescription No No AP 2023/03/15 SHENZHEN TECHDOW
214646 002 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 40MG/0.4ML (100MG/ML) Prescription No No AP 2023/06/06 BE PHARMS
活性成分:ENOXAPARIN SODIUM 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:60MG/0.6ML (100MG/ML) 治疗等效代码:AP
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
020164 003 NDA LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 60MG/0.6ML (100MG/ML) Prescription Yes No AP 1998/03/27 SANOFI AVENTIS US
077857 004 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 60MG/0.6ML (100MG/ML) Prescription No No AP 2010/07/23 SANDOZ
076684 003 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 60MG/0.6ML (100MG/ML) Prescription No No AP 2011/09/19 AMPHASTAR PHARM
076726 003 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 60MG/0.6ML (100MG/ML) Prescription No No AP 2014/06/23 ZYDUS PHARMS
078990 003 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 60MG/0.6ML (100MG/ML) Prescription No No AP 2018/09/28 GLAND
206834 003 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 60MG/0.6ML (100MG/ML) Prescription No No AP 2019/11/29 NANJING KING-FRIEND
205660 003 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 60MG/0.6ML (100MG/ML) Prescription No No AP 2023/03/15 SHENZHEN TECHDOW
214646 003 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 60MG/0.6ML (100MG/ML) Prescription No No AP 2023/06/06 BE PHARMS
活性成分:ENOXAPARIN SODIUM 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:80MG/0.8ML (100MG/ML) 治疗等效代码:AP
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
020164 004 NDA LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 80MG/0.8ML (100MG/ML) Prescription Yes No AP 1998/03/27 SANOFI AVENTIS US
077857 005 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 80MG/0.8ML (100MG/ML) Prescription No No AP 2010/07/23 SANDOZ
076684 004 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 80MG/0.8ML (100MG/ML) Prescription No No AP 2011/09/19 AMPHASTAR PHARM
076726 004 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 80MG/0.8ML (100MG/ML) Prescription No No AP 2014/06/23 ZYDUS PHARMS
078990 004 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 80MG/0.8ML (100MG/ML) Prescription No No AP 2018/09/28 GLAND
206834 004 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 80MG/0.8ML (100MG/ML) Prescription No No AP 2019/11/29 NANJING KING-FRIEND
205660 004 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 80MG/0.8ML (100MG/ML) Prescription No No AP 2023/03/15 SHENZHEN TECHDOW
214646 004 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 80MG/0.8ML (100MG/ML) Prescription No No AP 2023/06/06 BE PHARMS
活性成分:ENOXAPARIN SODIUM 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:100MG/ML (100MG/ML) 治疗等效代码:AP
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
020164 005 NDA LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 100MG/ML (100MG/ML) Prescription Yes Yes AP 1998/03/27 SANOFI AVENTIS US
077857 001 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 100MG/ML (100MG/ML) Prescription No No AP 2010/07/23 SANDOZ
076684 005 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 100MG/ML (100MG/ML) Prescription No No AP 2011/09/19 AMPHASTAR PHARM
076726 005 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 100MG/ML (100MG/ML) Prescription No No AP 2014/06/23 ZYDUS PHARMS
078990 005 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 100MG/ML (100MG/ML) Prescription No No AP 2018/09/28 GLAND
206834 005 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 100MG/ML (100MG/ML) Prescription No No AP 2019/11/29 NANJING KING-FRIEND
205660 005 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 100MG/ML (100MG/ML) Prescription No No AP 2023/03/15 SHENZHEN TECHDOW
214646 005 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 100MG/ML (100MG/ML) Prescription No No AP 2023/06/06 BE PHARMS
活性成分:ENOXAPARIN SODIUM 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:120MG/0.8ML (150MG/ML) 治疗等效代码:AP
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
020164 007 NDA LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 120MG/0.8ML (150MG/ML) Prescription Yes No AP 2000/06/02 SANOFI AVENTIS US
077857 006 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 120MG/0.8ML (150MG/ML) Prescription No No AP 2010/07/23 SANDOZ
076684 006 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 120MG/0.8ML (150MG/ML) Prescription No No AP 2011/09/19 AMPHASTAR PHARM
076726 006 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 120MG/0.8ML (150MG/ML) Prescription No No AP 2014/06/23 ZYDUS PHARMS
078990 006 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 120MG/0.8ML (150MG/ML) Prescription No No AP 2018/09/28 GLAND
206834 006 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 120MG/0.8ML (150MG/ML) Prescription No No AP 2019/11/29 NANJING KING-FRIEND
205660 006 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 120MG/0.8ML (150MG/ML) Prescription No No AP 2023/03/15 SHENZHEN TECHDOW
214646 006 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 120MG/0.8ML (150MG/ML) Prescription No No AP 2023/06/06 BE PHARMS
活性成分:ENOXAPARIN SODIUM 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:150MG/ML (150MG/ML) 治疗等效代码:AP
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
020164 008 NDA LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 150MG/ML (150MG/ML) Prescription Yes No AP 2000/06/02 SANOFI AVENTIS US
077857 007 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 150MG/ML (150MG/ML) Prescription No No AP 2010/07/23 SANDOZ
076684 007 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 150MG/ML (150MG/ML) Prescription No No AP 2011/09/19 AMPHASTAR PHARM
076726 007 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 150MG/ML (150MG/ML) Prescription No No AP 2014/06/23 ZYDUS PHARMS
078990 007 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 150MG/ML (150MG/ML) Prescription No No AP 2018/09/28 GLAND
206834 007 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 150MG/ML (150MG/ML) Prescription No No AP 2019/11/29 NANJING KING-FRIEND
205660 007 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 150MG/ML (150MG/ML) Prescription No No AP 2023/03/15 SHENZHEN TECHDOW
214646 007 ANDA ENOXAPARIN SODIUM (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 150MG/ML (150MG/ML) Prescription No No AP 2023/06/06 BE PHARMS
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