药品注册申请号：207486
申请类型：ANDA (仿制药申请)
申请人：HIKMA
申请人全名：HIKMA PHARMACEUTICALS USA 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 EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG No No AB;AB 2021/11/23 2020/06/08 Prescription
002 EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG No No AB;AB 2020/06/08 Prescription
003 EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG No No AB;AB 2020/06/08 Prescription
004 EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG No No AB;AB 2021/11/23 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
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
2021/11/23 ORIG-2（原始申请） Approval STANDARD
2020/06/08 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:EVEROLIMUS 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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RLDRSTE Code产品号批准日期申请人
022334 003 NDA AFINITOR EVEROLIMUS TABLET;ORAL 2.5MG Prescription Yes No AB 2010/07/09 NOVARTIS
207934 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2019/12/09 ENDO OPERATIONS
210050 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2019/12/09 TEVA PHARMS USA
212936 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2020/06/08 MYLAN
207486 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2020/06/08 HIKMA
214182 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2021/02/11 BIOCON PHARMA
205426 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2021/03/05 BRECKENRIDGE
活性成分:EVEROLIMUS 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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RLDRSTE Code产品号批准日期申请人
022334 003 NDA AFINITOR EVEROLIMUS TABLET;ORAL 2.5MG Prescription Yes No AB 2010/07/09 NOVARTIS
207934 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2019/12/09 ENDO OPERATIONS
210050 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2019/12/09 TEVA PHARMS USA
212936 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2020/06/08 MYLAN
207486 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2020/06/08 HIKMA
214182 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2021/02/11 BIOCON PHARMA
205426 001 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 2.5MG Prescription No No AB 2021/03/05 BRECKENRIDGE
活性成分:EVEROLIMUS 剂型/给药途径:TABLET;ORAL 规格:5MG 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RLDRSTE Code产品号批准日期申请人
022334 001 NDA AFINITOR EVEROLIMUS TABLET;ORAL 5MG Prescription Yes Yes AB 2009/03/30 NOVARTIS
207934 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2019/12/09 ENDO OPERATIONS
210050 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2019/12/09 TEVA PHARMS USA
212936 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2020/06/08 MYLAN
207486 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2020/06/08 HIKMA
214182 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2021/02/11 BIOCON PHARMA
205426 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2021/03/05 BRECKENRIDGE
活性成分:EVEROLIMUS 剂型/给药途径:TABLET;ORAL 规格:5MG 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RLDRSTE Code产品号批准日期申请人
022334 001 NDA AFINITOR EVEROLIMUS TABLET;ORAL 5MG Prescription Yes Yes AB 2009/03/30 NOVARTIS
207934 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2019/12/09 ENDO OPERATIONS
210050 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2019/12/09 TEVA PHARMS USA
212936 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2020/06/08 MYLAN
207486 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2020/06/08 HIKMA
214182 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2021/02/11 BIOCON PHARMA
205426 002 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 5MG Prescription No No AB 2021/03/05 BRECKENRIDGE
活性成分:EVEROLIMUS 剂型/给药途径:TABLET;ORAL 规格:7.5MG 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RLDRSTE Code产品号批准日期申请人
022334 004 NDA AFINITOR EVEROLIMUS TABLET;ORAL 7.5MG Prescription Yes No AB 2012/03/30 NOVARTIS
207934 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2019/12/09 ENDO OPERATIONS
210050 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2019/12/09 TEVA PHARMS USA
212936 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2020/06/08 MYLAN
207486 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2020/06/08 HIKMA
214182 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2021/02/11 BIOCON PHARMA
205426 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2021/03/05 BRECKENRIDGE
活性成分:EVEROLIMUS 剂型/给药途径:TABLET;ORAL 规格:7.5MG 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RLDRSTE Code产品号批准日期申请人
022334 004 NDA AFINITOR EVEROLIMUS TABLET;ORAL 7.5MG Prescription Yes No AB 2012/03/30 NOVARTIS
207934 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2019/12/09 ENDO OPERATIONS
210050 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2019/12/09 TEVA PHARMS USA
212936 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2020/06/08 MYLAN
207486 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2020/06/08 HIKMA
214182 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2021/02/11 BIOCON PHARMA
205426 003 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 7.5MG Prescription No No AB 2021/03/05 BRECKENRIDGE
活性成分:EVEROLIMUS 剂型/给药途径:TABLET;ORAL 规格:10MG 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RLDRSTE Code产品号批准日期申请人
022334 002 NDA AFINITOR EVEROLIMUS TABLET;ORAL 10MG Prescription Yes No AB 2009/03/30 NOVARTIS
210050 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2019/12/09 TEVA PHARMS USA
212936 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2020/06/08 MYLAN
207934 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2020/12/09 ENDO OPERATIONS
214182 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2021/02/11 BIOCON PHARMA
205426 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2021/03/05 BRECKENRIDGE
207486 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2021/11/23 HIKMA
活性成分:EVEROLIMUS 剂型/给药途径:TABLET;ORAL 规格:10MG 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RLDRSTE Code产品号批准日期申请人
022334 002 NDA AFINITOR EVEROLIMUS TABLET;ORAL 10MG Prescription Yes No AB 2009/03/30 NOVARTIS
210050 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2019/12/09 TEVA PHARMS USA
212936 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2020/06/08 MYLAN
207934 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2020/12/09 ENDO OPERATIONS
214182 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2021/02/11 BIOCON PHARMA
205426 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2021/03/05 BRECKENRIDGE
207486 004 ANDA EVEROLIMUS EVEROLIMUS TABLET;ORAL 10MG Prescription No No AB 2021/11/23 HIKMA
更多信息
药品NDC数据与药品包装、标签说明书
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