药品注册申请号:040745
申请类型:ANDA (仿制药申请)
申请人:BAXTER HLTHCARE
申请人全名:BAXTER HEALTHCARE CORP
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 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 500MG/VIAL No Yes AP 2008/05/21 2008/05/21 Prescription
002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 1GM/VIAL No Yes AP 2008/05/21 Prescription
003 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 2GM/VIAL No Yes AP 2008/05/21 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
2024/03/29 SUPPL-4(补充) Approval Labeling STANDARD
2014/10/25 SUPPL-3(补充) Approval Labeling STANDARD
2013/06/17 SUPPL-2(补充) Approval Labeling STANDARD
2008/05/21 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
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:CYCLOPHOSPHAMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:500MG/VIAL 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
040745 001 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 500MG/VIAL Prescription No Yes AP 2008/05/21 BAXTER HLTHCARE
204555 001 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 500MG/VIAL Prescription No No AP 2014/10/31 HENGRUI PHARMA
210046 001 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 500MG/VIAL Prescription No No AP 2018/05/25 AMNEAL
211757 001 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 500MG/VIAL Prescription No No AP 2022/10/18 XGEN PHARMS
214529 001 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 500MG/VIAL Prescription No No AP 2023/07/17 SAGENT PHARMS INC
215089 001 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 500MG/VIAL Prescription No No AP 2023/10/26 SUNNY
216958 001 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 500MG/VIAL Prescription No No AP 2023/12/18 HIKMA
活性成分:CYCLOPHOSPHAMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1GM/VIAL 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
040745 002 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 1GM/VIAL Prescription No Yes AP 2008/05/21 BAXTER HLTHCARE
204555 002 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 1GM/VIAL Prescription No No AP 2014/10/31 HENGRUI PHARMA
210046 002 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 1GM/VIAL Prescription No No AP 2018/05/25 AMNEAL
211757 002 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 1GM/VIAL Prescription No No AP 2022/10/18 XGEN PHARMS
214529 002 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 1GM/VIAL Prescription No No AP 2023/07/17 SAGENT PHARMS INC
215089 002 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 1GM/VIAL Prescription No No AP 2023/10/26 SUNNY
216958 002 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 1GM/VIAL Prescription No No AP 2023/12/18 HIKMA
活性成分:CYCLOPHOSPHAMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2GM/VIAL 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
040745 003 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 2GM/VIAL Prescription No Yes AP 2008/05/21 BAXTER HLTHCARE
204555 003 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 2014/10/31 HENGRUI PHARMA
210046 003 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 2018/05/25 AMNEAL
211757 003 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 2022/10/18 XGEN PHARMS
214529 003 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 2023/07/17 SAGENT PHARMS INC
215089 003 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 2023/10/26 SUNNY
216958 003 ANDA CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 2023/12/18 HIKMA
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