药品注册申请号:207325
申请类型:ANDA (仿制药申请)
申请人:GLAND
申请人全名:GLAND PHARMA 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 OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) No No AP 2017/02/10 2017/02/10 Prescription
002 OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) No No AP 2017/02/10 Prescription
003 OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 200MG/40ML (5MG/ML) No No None 2017/10/18 Discontinued
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
2023/12/11 SUPPL-9(补充) Approval Labeling STANDARD
2021/12/15 SUPPL-4(补充) Approval Labeling STANDARD
2017/02/10 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
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
与本品治疗等效的药品
活性成分:OXALIPLATIN 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:50MG/10ML (5MG/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
021759 001 NDA ELOXATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription Yes Yes AP 2005/01/31 SANOFI AVENTIS US
022160 001 NDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription Yes Yes AP 2009/08/07 TEVA PHARMS
078813 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2009/08/07 HOSPIRA WORLDWIDE
078811 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2010/06/10 FRESENIUS KABI USA
078817 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2011/01/24 SANDOZ
091358 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2012/08/07 MYLAN LABS LTD
203869 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2014/06/18 HENGRUI PHARMA
204368 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2016/06/07 QILU PHARM HAINAN
090030 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2017/01/31 FRESENIUS KABI USA
207325 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2017/02/10 GLAND
207474 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2017/03/21 ACCORD HLTHCARE
205529 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2017/09/06 EUGIA PHARMA
204880 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2018/03/05 ACTAVIS
207562 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2018/10/16 NOVAST LABS
217348 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2024/01/11 KINDOS
活性成分:OXALIPLATIN 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:100MG/20ML (5MG/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
021759 002 NDA ELOXATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription Yes Yes AP 2005/01/31 SANOFI AVENTIS US
022160 002 NDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription Yes Yes AP 2009/08/07 TEVA PHARMS
078813 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2009/08/07 HOSPIRA WORLDWIDE
078811 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2010/06/10 FRESENIUS KABI USA
078817 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2011/01/24 SANDOZ
091358 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2012/08/07 MYLAN LABS LTD
203869 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2014/06/18 HENGRUI PHARMA
204368 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2016/06/07 QILU PHARM HAINAN
090030 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2017/01/31 FRESENIUS KABI USA
207325 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2017/02/10 GLAND
207474 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2017/03/21 ACCORD HLTHCARE
205529 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2017/09/06 EUGIA PHARMA
204880 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2018/03/05 ACTAVIS
207562 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2018/10/16 NOVAST LABS
217348 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2024/01/11 KINDOS
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