药品注册申请号：091558
申请类型：ANDA (仿制药申请)
申请人：APOTEX INC
申请人全名：APOTEX 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 MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE No No AB;AB 2012/08/21 2012/08/21 Prescription
002 MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE No No AB;AB 2014/08/19 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
2023/11/28 SUPPL-19（补充） Approval Labeling STANDARD
2023/11/28 SUPPL-17（补充） Approval Labeling STANDARD
2023/11/28 SUPPL-14（补充） Approval Labeling STANDARD
2021/08/11 SUPPL-18（补充） Approval REMS
2021/04/21 SUPPL-16（补充） Approval REMS
2021/01/15 SUPPL-12（补充） Approval REMS
2019/12/31 SUPPL-8（补充） Approval Labeling STANDARD
2015/11/13 SUPPL-6（补充） Approval REMS
2014/08/19 ORIG-2（原始申请） Approval
2014/06/26 SUPPL-3（补充） Approval Labeling STANDARD
2013/09/30 SUPPL-2（补充） Approval REMS
2012/09/25 SUPPL-1（补充） Approval REMS
2012/08/21 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
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:MYCOPHENOLIC SODIUM 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:EQ 180MG BASE 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
050791 001 NDA MYFORTIC MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription Yes No AB 2004/02/27 NOVARTIS
091558 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2012/08/21 APOTEX INC
091248 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2014/01/08 RK PHARMA
202555 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2017/08/23 ACCORD HLTHCARE
211173 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2019/12/13 CONCORD BIOTECH LTD
214376 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2021/02/10 AMTA
208315 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2021/09/23 ALKEM LABS LTD
214289 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2021/11/03 TWI PHARMS
214630 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2021/11/29 BIOCON PHARMA
217031 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2023/11/29 SKG PHARMA
218603 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2024/02/27 AUROBINDO PHARMA LTD
活性成分:MYCOPHENOLIC SODIUM 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:EQ 180MG BASE 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
050791 001 NDA MYFORTIC MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription Yes No AB 2004/02/27 NOVARTIS
091558 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2012/08/21 APOTEX INC
091248 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2014/01/08 RK PHARMA
202555 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2017/08/23 ACCORD HLTHCARE
211173 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2019/12/13 CONCORD BIOTECH LTD
214376 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2021/02/10 AMTA
208315 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2021/09/23 ALKEM LABS LTD
214289 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2021/11/03 TWI PHARMS
214630 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2021/11/29 BIOCON PHARMA
217031 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2023/11/29 SKG PHARMA
218603 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 180MG BASE Prescription No No AB 2024/02/27 AUROBINDO PHARMA LTD
活性成分:MYCOPHENOLIC SODIUM 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:EQ 360MG BASE 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
050791 002 NDA MYFORTIC MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription Yes Yes AB 2004/02/27 NOVARTIS
091248 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2014/01/08 RK PHARMA
091558 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2014/08/19 APOTEX INC
202555 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2017/08/23 ACCORD HLTHCARE
211173 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2019/12/13 CONCORD BIOTECH LTD
214376 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2021/02/10 AMTA
208315 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2021/09/23 ALKEM LABS LTD
214289 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2021/11/03 TWI PHARMS
214630 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2021/11/29 BIOCON PHARMA
217031 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2023/11/29 SKG PHARMA
218603 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2024/02/27 AUROBINDO PHARMA LTD
活性成分:MYCOPHENOLIC SODIUM 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:EQ 360MG BASE 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
050791 002 NDA MYFORTIC MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription Yes Yes AB 2004/02/27 NOVARTIS
091248 001 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2014/01/08 RK PHARMA
091558 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2014/08/19 APOTEX INC
202555 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2017/08/23 ACCORD HLTHCARE
211173 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2019/12/13 CONCORD BIOTECH LTD
214376 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2021/02/10 AMTA
208315 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2021/09/23 ALKEM LABS LTD
214289 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2021/11/03 TWI PHARMS
214630 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2021/11/29 BIOCON PHARMA
217031 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2023/11/29 SKG PHARMA
218603 002 ANDA MYCOPHENOLIC SODIUM MYCOPHENOLIC SODIUM TABLET, DELAYED RELEASE;ORAL EQ 360MG BASE Prescription No No AB 2024/02/27 AUROBINDO PHARMA LTD
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database