药品注册申请号：020164
申请类型：NDA (新药申请)
申请人：SANOFI AVENTIS US
申请人全名：SANOFI AVENTIS US LLC
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 LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 30MG/0.3ML (100MG/ML) Yes No AP 1993/03/29 1993/03/29 Prescription
002 LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 40MG/0.4ML (100MG/ML) Yes No AP 1998/01/30 Prescription
003 LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 60MG/0.6ML (100MG/ML) Yes No AP 1998/03/27 Prescription
004 LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 80MG/0.8ML (100MG/ML) Yes No AP 1998/03/27 Prescription
005 LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 100MG/ML (100MG/ML) Yes Yes AP 1998/03/27 Prescription
006 LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2000/06/02 Discontinued
007 LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 120MG/0.8ML (150MG/ML) Yes No AP 2000/06/02 Prescription
008 LOVENOX (PRESERVATIVE FREE) ENOXAPARIN SODIUM INJECTABLE;SUBCUTANEOUS 150MG/ML (150MG/ML) Yes No AP 2000/06/02 Prescription
009 LOVENOX ENOXAPARIN SODIUM INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 300MG/3ML (100MG/ML) Yes No AB 2003/01/23 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
2023/07/28 SUPPL-101（补充） Approval Labeling STANDARD
2022/12/01 SUPPL-131（补充） Approval Labeling STANDARD
2021/12/20 SUPPL-129（补充） Approval Labeling STANDARD
2018/12/11 SUPPL-116（补充） Approval Labeling STANDARD
2017/10/26 SUPPL-110（补充） Approval Labeling STANDARD
2017/01/30 SUPPL-108（补充） Approval Manufacturing (CMC) STANDARD
2015/08/24 SUPPL-107（补充） Approval Manufacturing (CMC) PRIORITY
2015/08/03 SUPPL-106（补充） Approval Manufacturing (CMC) PRIORITY
2014/05/29 SUPPL-105（补充） Approval Manufacturing (CMC) PRIORITY
2013/10/23 SUPPL-102（补充） Approval Labeling STANDARD
2013/09/27 SUPPL-103（补充） Approval Manufacturing (CMC) PRIORITY
2013/09/06 SUPPL-98（补充） Approval Manufacturing (CMC) PRIORITY
2013/06/05 SUPPL-100（补充） Approval Labeling STANDARD
2012/12/10 SUPPL-79（补充） Approval Manufacturing (CMC) PRIORITY
2012/12/06 SUPPL-89（补充） Approval Manufacturing (CMC) PRIORITY
2012/11/28 SUPPL-99（补充） Approval Manufacturing (CMC) PRIORITY
2011/04/20 SUPPL-93（补充） Approval Labeling STANDARD
2011/04/13 SUPPL-92（补充） Approval Labeling STANDARD
2009/12/23 SUPPL-85（补充） Approval Labeling STANDARD
2009/07/27 SUPPL-83（补充） Approval Labeling STANDARD
2008/07/16 SUPPL-80（补充） Approval Labeling STANDARD
2007/05/16 SUPPL-75（补充） Approval Labeling STANDARD
2007/01/12 SUPPL-70（补充） Approval Manufacturing (CMC) N/A
2005/03/07 SUPPL-63（补充） Approval Labeling STANDARD
2004/10/20 SUPPL-53（补充） Approval Manufacturing (CMC) PRIORITY
2004/07/23 SUPPL-55（补充） Approval Manufacturing (CMC) PRIORITY
2004/05/18 SUPPL-57（补充） Approval Labeling STANDARD
2004/04/21 SUPPL-58（补充） Approval Labeling STANDARD
2004/04/13 SUPPL-56（补充） Approval Labeling STANDARD
2003/12/18 SUPPL-48（补充） Approval Labeling STANDARD
2003/07/01 SUPPL-50（补充） Approval Labeling STANDARD
2003/06/20 SUPPL-51（补充） Approval Labeling STANDARD
2003/01/23 SUPPL-43（补充） Approval Manufacturing (CMC) PRIORITY
2002/01/09 SUPPL-46（补充） Approval Labeling STANDARD
2002/01/09 SUPPL-45（补充） Approval Labeling STANDARD
2002/01/09 SUPPL-40（补充） Approval Labeling STANDARD
2001/11/30 SUPPL-44（补充） Approval Manufacturing (CMC) PRIORITY
2001/07/05 SUPPL-42（补充） Approval Manufacturing (CMC) PRIORITY
2000/12/14 SUPPL-41（补充） Approval Manufacturing (CMC) PRIORITY
2000/11/17 SUPPL-37（补充） Approval Labeling STANDARD
2000/11/17 SUPPL-36（补充） Approval Efficacy PRIORITY
2000/10/24 SUPPL-39（补充） Approval Manufacturing (CMC) PRIORITY
2000/08/03 SUPPL-20（补充） Approval Efficacy UNKNOWN
2000/06/20 SUPPL-38（补充） Approval Manufacturing (CMC) PRIORITY
2000/06/02 SUPPL-30（补充） Approval Manufacturing (CMC) PRIORITY
2000/05/30 SUPPL-34（补充） Approval Efficacy STANDARD
2000/04/04 SUPPL-35（补充） Approval Manufacturing (CMC) PRIORITY
2000/01/27 SUPPL-32（补充） Approval Manufacturing (CMC) PRIORITY
1999/11/08 SUPPL-23（补充） Approval Manufacturing (CMC) PRIORITY
1999/10/05 SUPPL-31（补充） Approval Labeling STANDARD
1999/10/05 SUPPL-27（补充） Approval Manufacturing (CMC) PRIORITY
1999/09/28 SUPPL-28（补充） Approval Labeling STANDARD
1999/09/14 SUPPL-26（补充） Approval Manufacturing (CMC) PRIORITY
1999/07/22 SUPPL-24（补充） Approval Manufacturing (CMC) PRIORITY
1999/07/21 SUPPL-22（补充） Approval Manufacturing (CMC) PRIORITY
1999/04/20 SUPPL-21（补充） Approval Labeling STANDARD
1999/03/03 SUPPL-19（补充） Approval Manufacturing (CMC) PRIORITY
1998/12/31 SUPPL-15（补充） Approval Efficacy STANDARD
1998/03/27 SUPPL-16（补充） Approval Efficacy PRIORITY
1998/02/24 SUPPL-11（补充） Approval Manufacturing (CMC) PRIORITY
1998/01/30 SUPPL-10（补充） Approval Efficacy UNKNOWN
1997/05/27 SUPPL-17（补充） Approval Labeling STANDARD
1997/05/27 SUPPL-6（补充） Approval Labeling STANDARD
1997/05/16 SUPPL-13（补充） Approval Manufacturing (CMC) PRIORITY
1997/05/06 SUPPL-8（补充） Approval Efficacy STANDARD
1997/03/07 SUPPL-7（补充） Approval Manufacturing (CMC) PRIORITY
1997/01/27 SUPPL-14（补充） Approval Labeling STANDARD
1996/10/23 SUPPL-12（补充） Approval Manufacturing (CMC) PRIORITY
1996/06/26 SUPPL-9（补充） Approval Manufacturing (CMC) PRIORITY
1996/03/15 SUPPL-4（补充） Approval Manufacturing (CMC) PRIORITY
1996/01/30 SUPPL-5（补充） Approval Labeling STANDARD
1995/03/09 SUPPL-2（补充） Approval Efficacy STANDARD
1994/03/14 SUPPL-1（补充） Approval Labeling STANDARD
1993/03/29 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity PRIORITY
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
001 5389618 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
RE38743 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5389618 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
RE38743 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5389618 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
RE38743 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5389618 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
RE38743 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5389618 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
RE38743 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
006 5389618 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
RE38743 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
007 5389618 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
RE38743 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
008 5389618 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
RE38743 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
009 5389618 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
RE38743 2012/02/14 Y Y U-545 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 I-533 2010/05/16**本条是由Drugfuture回溯的历史信息**
002 I-533 2010/05/16**本条是由Drugfuture回溯的历史信息**
003 I-533 2010/05/16**本条是由Drugfuture回溯的历史信息**
004 I-533 2010/05/16**本条是由Drugfuture回溯的历史信息**
005 I-533 2010/05/16**本条是由Drugfuture回溯的历史信息**
006 I-533 2010/05/16**本条是由Drugfuture回溯的历史信息**
007 I-533 2010/05/16**本条是由Drugfuture回溯的历史信息**
008 I-533 2010/05/16**本条是由Drugfuture回溯的历史信息**
009 I-533 2010/05/16**本条是由Drugfuture回溯的历史信息**
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
活性成分:ENOXAPARIN SODIUM 剂型/给药途径:INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 规格:300MG/3ML (100MG/ML) 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
020164 009 NDA LOVENOX ENOXAPARIN SODIUM INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 300MG/3ML (100MG/ML) Prescription Yes No AB 2003/01/23 SANOFI AVENTIS US
078660 001 ANDA ENOXAPARIN SODIUM ENOXAPARIN SODIUM INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 300MG/3ML (100MG/ML) Prescription No No AB 2011/11/28 SANDOZ INC
208600 001 ANDA ENOXAPARIN SODIUM ENOXAPARIN SODIUM INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 300MG/3ML (100MG/ML) Prescription No No AB 2019/03/14 AMPHASTAR PHARMS INC
214856 001 ANDA ENOXAPARIN SODIUM ENOXAPARIN SODIUM INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 300MG/3ML (100MG/ML) Prescription No No AB 2022/06/14 NANJING KING-FRIEND
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