药品注册申请号：211817
申请类型：ANDA (仿制药申请)
申请人：EUGIA PHARMA
申请人全名：EUGIA PHARMA SPECIALITIES 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 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 100MG/ML No No AO 2023/10/20 2023/10/20 Prescription
002 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML No No AO 2023/10/20 Prescription
003 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML No No AO -- 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
2023/10/20 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
无
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
无
与本品治疗等效的药品
活性成分:TESTOSTERONE CYPIONATE 剂型/给药途径:INJECTABLE;INJECTION 规格:100MG/ML 治疗等效代码:AO
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
085635 002 ANDA DEPO-TESTOSTERONE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 100MG/ML Prescription Yes Yes AO Approved Prior to Jan 1, 1982 PFIZER
040615 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 100MG/ML Prescription No No AO 2006/08/10 SANDOZ
090387 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 100MG/ML Prescription No No AO 2010/07/15 HIKMA
201720 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 100MG/ML Discontinued No No AO 2013/06/03 SUN PHARM INDS LTD
210362 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 100MG/ML Prescription No No AO 2018/06/19 CIPLA
215351 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 100MG/ML Prescription No No AO 2023/04/13 XIROMED
211817 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 100MG/ML Prescription No No AO 2023/10/20 EUGIA PHARMA
活性成分:TESTOSTERONE CYPIONATE 剂型/给药途径:INJECTABLE;INJECTION 规格:200MG/ML 治疗等效代码:AO
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
211817 003 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO -- EUGIA PHARMA
085635 003 ANDA DEPO-TESTOSTERONE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription Yes Yes AO Approved Prior to Jan 1, 1982 PFIZER
086030 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Discontinued No No AO Approved Prior to Jan 1, 1982 WATSON PHARMS INC
040530 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2005/01/31 PADAGIS US
040615 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2006/08/10 SANDOZ
090387 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2010/07/15 HIKMA
091244 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2012/05/01 HIKMA FARMACEUTICA
201720 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Discontinued No No AO 2013/06/03 SUN PHARM INDS LTD
207742 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2017/06/16 AM REGENT
210362 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2018/06/19 CIPLA
206368 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2019/04/24 WILSHIRE PHARMS INC
215351 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2023/04/13 XIROMED
211817 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2023/10/20 EUGIA PHARMA
活性成分:TESTOSTERONE CYPIONATE 剂型/给药途径:INJECTABLE;INJECTION 规格:200MG/ML 治疗等效代码:AO
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
211817 003 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO -- EUGIA PHARMA
085635 003 ANDA DEPO-TESTOSTERONE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription Yes Yes AO Approved Prior to Jan 1, 1982 PFIZER
086030 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Discontinued No No AO Approved Prior to Jan 1, 1982 WATSON PHARMS INC
040530 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2005/01/31 PADAGIS US
040615 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2006/08/10 SANDOZ
090387 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2010/07/15 HIKMA
091244 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2012/05/01 HIKMA FARMACEUTICA
201720 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Discontinued No No AO 2013/06/03 SUN PHARM INDS LTD
207742 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2017/06/16 AM REGENT
210362 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2018/06/19 CIPLA
206368 001 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2019/04/24 WILSHIRE PHARMS INC
215351 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2023/04/13 XIROMED
211817 002 ANDA TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE INJECTABLE;INJECTION 200MG/ML Prescription No No AO 2023/10/20 EUGIA PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
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