药品注册申请号:204693
申请类型:ANDA (仿制药申请)
申请人:SAGENT PHARMS INC
申请人全名:SAGENT PHARMACEUTICALS 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 EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 2MG/ML No No AP 2018/03/07 2018/03/07 Prescription
002 EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 75MG/100ML No No AP 2018/03/07 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
2018/03/07 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:EPTIFIBATIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2MG/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
090854 001 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 2MG/ML Prescription No No AP 2015/06/12 TEVA PHARMS USA
206127 001 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 2MG/ML Prescription No No AP 2015/12/08 EUGIA PHARMA
204589 001 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 2MG/ML Discontinued No No AP 2017/04/18 RISING
205557 001 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 2MG/ML Discontinued No No AP 2017/11/06 ACCORD HLTHCARE
204693 001 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 2MG/ML Prescription No No AP 2018/03/07 SAGENT PHARMS INC
203258 001 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 2MG/ML Prescription No Yes AP 2018/07/20 MYLAN LABS LTD
208554 001 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 2MG/ML Discontinued No No AP 2018/11/23 BAXTER HLTHCARE CORP
209864 001 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 2MG/ML Prescription No No AP 2019/01/25 SLATE RUN PHARMA
213081 001 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 2MG/ML Prescription No No AP 2021/09/07 SHUANGCHENG
213599 001 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 2MG/ML Prescription No No AP 2024/05/09 HONG KONG
活性成分:EPTIFIBATIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:75MG/100ML 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
206127 002 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 75MG/100ML Prescription No No AP 2015/12/08 EUGIA PHARMA
204589 002 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 75MG/100ML Discontinued No No AP 2017/04/18 RISING
205557 002 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 75MG/100ML Discontinued No No AP 2017/11/06 ACCORD HLTHCARE
204693 002 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 75MG/100ML Prescription No No AP 2018/03/07 SAGENT PHARMS INC
203258 002 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 75MG/100ML Prescription No Yes AP 2018/07/20 MYLAN LABS LTD
208554 002 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 75MG/100ML Prescription No No AP 2018/11/23 BAXTER HLTHCARE CORP
209864 002 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 75MG/100ML Prescription No No AP 2019/01/25 SLATE RUN PHARMA
213081 002 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 75MG/100ML Prescription No No AP 2022/04/20 SHUANGCHENG
213599 002 ANDA EPTIFIBATIDE EPTIFIBATIDE INJECTABLE;INJECTION 75MG/100ML Prescription No No AP 2024/05/09 HONG KONG
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药品NDC数据与药品包装、标签说明书
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