LOVENOX (PRESERVATIVE FREE)-美国FDA药品数据库-药物在线

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INJECTABLE;SUBCUTANEOUS	90MG/0.6ML (150MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	2000/06/02	Discontinued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

>>>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
1993/03/29	ORIG-1（原始申请）	Approval	Type 1 - New Molecular Entity	PRIORITY	Label Other Important Information from FDA Review Letter

>>>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
2023/07/28	SUPPL-101（补充）	Approval	Labeling-Package Insert	STANDARD	Label Letter
2022/12/01	SUPPL-131（补充）	Approval	Labeling-Package Insert	STANDARD	Letter Label
2021/12/20	SUPPL-129（补充）	Approval	Labeling-Package Insert	STANDARD	Label Letter
2018/12/11	SUPPL-116（补充）	Approval	Labeling-Package Insert	STANDARD	Label Letter
2017/10/26	SUPPL-110（补充）	Approval	Labeling-Package Insert	STANDARD	Letter Label
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-Package Insert	STANDARD	Label Letter
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-Package Insert	STANDARD	Label Letter
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-Package Insert	STANDARD	Letter Label
2011/04/13	SUPPL-92（补充）	Approval	Labeling-Package Insert	STANDARD	Label Letter
2009/12/23	SUPPL-85（补充）	Approval	Labeling	STANDARD	Letter Label
2009/07/27	SUPPL-83（补充）	Approval	Labeling	STANDARD	Label Letter
2008/07/16	SUPPL-80（补充）	Approval	Labeling	STANDARD	Letter Label
2007/05/16	SUPPL-75（补充）	Approval	Labeling	STANDARD	Review Letter Label
2007/01/12	SUPPL-70（补充）	Approval	Labeling-Package Insert,Labeling-Container/Carton Labels	N/A	Label Letter
2005/03/07	SUPPL-63（补充）	Approval	Labeling	STANDARD	Letter
2004/10/20	SUPPL-53（补充）	Approval	Manufacturing (CMC)	PRIORITY	Letter
2004/07/23	SUPPL-55（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY	Review Letter Label
2004/05/18	SUPPL-57（补充）	Approval	Labeling	STANDARD	Review Letter
2004/04/21	SUPPL-58（补充）	Approval	Labeling	STANDARD	Review Letter
2004/04/13	SUPPL-56（补充）	Approval	Labeling	STANDARD	Review Letter
2003/12/18	SUPPL-48（补充）	Approval	Labeling	STANDARD	Letter
2003/07/01	SUPPL-50（补充）	Approval	Labeling	STANDARD	Review Letter
2003/06/20	SUPPL-51（补充）	Approval	Labeling	STANDARD	Letter Review
2003/01/23	SUPPL-43（补充）	Approval	Manufacturing (CMC)	PRIORITY	Review Letter
2002/01/09	SUPPL-46（补充）	Approval	Labeling	STANDARD	Letter Review
2002/01/09	SUPPL-45（补充）	Approval	Labeling	STANDARD	Review Letter
2002/01/09	SUPPL-40（补充）	Approval	Labeling	STANDARD	Review Letter
2001/11/30	SUPPL-44（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY	Review
2001/07/05	SUPPL-42（补充）	Approval	Manufacturing (CMC)	PRIORITY	Review
2000/12/14	SUPPL-41（补充）	Approval	Manufacturing (CMC)	PRIORITY	Review
2000/11/17	SUPPL-37（补充）	Approval	Labeling	STANDARD	Letter Label
2000/11/17	SUPPL-36（补充）	Approval	Efficacy-New Indication	PRIORITY	Label Letter
2000/10/24	SUPPL-39（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY	Review
2000/08/03	SUPPL-20（补充）	Approval	Efficacy-Labeling Change With Clinical Data	UNKNOWN	Letter
2000/06/20	SUPPL-38（补充）	Approval	Manufacturing (CMC)	PRIORITY	Review
2000/06/02	SUPPL-30（补充）	Approval	Manufacturing (CMC)-Formulation	PRIORITY	Review
2000/05/30	SUPPL-34（补充）	Approval	Efficacy-Labeling Change With Clinical Data	STANDARD	Letter
2000/04/04	SUPPL-35（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
2000/01/27	SUPPL-32（补充）	Approval	Manufacturing (CMC)	PRIORITY	Review
1999/11/08	SUPPL-23（补充）	Approval	Manufacturing (CMC)	PRIORITY	Review
1999/10/05	SUPPL-31（补充）	Approval	Labeling	STANDARD
1999/10/05	SUPPL-27（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY
1999/09/28	SUPPL-28（补充）	Approval	Labeling	STANDARD
1999/09/14	SUPPL-26（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY	Review
1999/07/22	SUPPL-24（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY	Review
1999/07/21	SUPPL-22（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY	Review
1999/04/20	SUPPL-21（补充）	Approval	Labeling	STANDARD	Review
1999/03/03	SUPPL-19（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY	Review
1998/12/31	SUPPL-15（补充）	Approval	Efficacy-New Indication	STANDARD	Review Label Letter
1998/03/27	SUPPL-16（补充）	Approval	Efficacy-New Indication	PRIORITY
1998/02/24	SUPPL-11（补充）	Approval	Manufacturing (CMC)-Control	PRIORITY	Review
1998/01/30	SUPPL-10（补充）	Approval	Efficacy-New Indication	UNKNOWN	Review Letter
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	Review
1997/05/06	SUPPL-8（补充）	Approval	Efficacy-New Indication	STANDARD
1997/03/07	SUPPL-7（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY
1997/01/27	SUPPL-14（补充）	Approval	Labeling	STANDARD
1996/10/23	SUPPL-12（补充）	Approval	Manufacturing (CMC)	PRIORITY	Review
1996/06/26	SUPPL-9（补充）	Approval	Manufacturing (CMC)-Packaging	PRIORITY	Review
1996/03/15	SUPPL-4（补充）	Approval	Manufacturing (CMC)	PRIORITY	Review
1996/01/30	SUPPL-5（补充）	Approval	Labeling	STANDARD	Review
1995/03/09	SUPPL-2（补充）	Approval	Efficacy-New Indication	STANDARD
1994/03/14	SUPPL-1（补充）	Approval	Labeling	STANDARD

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	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

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	RLD	RS	TE 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	EMERGE BIOSCIENCE
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	RLD	RS	TE 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	EMERGE BIOSCIENCE
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	RLD	RS	TE 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	EMERGE BIOSCIENCE
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	RLD	RS	TE 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	EMERGE BIOSCIENCE
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	RLD	RS	TE 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	EMERGE BIOSCIENCE
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	RLD	RS	TE 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	EMERGE BIOSCIENCE
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	RLD	RS	TE 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	EMERGE BIOSCIENCE
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	RLD	RS	TE 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	EMERGE BIOSCIENCE