药品注册申请号：203740
申请类型：ANDA (仿制药申请)
申请人：ALKEM LABS LTD
申请人全名：ALKEM LABORATORIES 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 TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE No No AB 2020/11/12 2020/11/12 Prescription
002 TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE No No AB 2020/11/12 Prescription
003 TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE No No AB 2020/11/12 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
2023/04/19 SUPPL-9（补充） Approval Labeling STANDARD
2023/04/19 SUPPL-5（补充） Approval Labeling STANDARD
2023/04/19 SUPPL-3（补充） Approval Labeling STANDARD
2020/11/12 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:TACROLIMUS 剂型/给药途径:CAPSULE;ORAL 规格:EQ 0.5MG 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
050708 003 NDA PROGRAF TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription Yes No AB 1998/08/24 ASTELLAS
065461 001 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription No No AB 2009/08/10 SANDOZ
090509 001 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription No No AB 2010/05/12 DR REDDYS LABS LTD
090596 001 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription No No AB 2010/09/17 MYLAN
090802 001 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription No No AB 2012/09/28 PANACEA
090687 001 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription No No AB 2014/07/22 STRIDES PHARMA
206651 001 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription No No AB 2017/11/30 BELCHER
206662 001 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription No No AB 2020/11/10 GLENMARK PHARMS LTD
212297 001 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription No No AB 2020/11/10 BIOCON PHARMA
213112 001 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription No No AB 2020/11/10 CONCORD BIOTECH LTD
203740 001 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription No No AB 2020/11/12 ALKEM LABS LTD
210929 001 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Prescription No No AB 2023/04/17 HANGZHOU ZHONGMEI
活性成分:TACROLIMUS 剂型/给药途径:CAPSULE;ORAL 规格:EQ 1MG 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
050708 001 NDA PROGRAF TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription Yes No AB 1994/04/08 ASTELLAS
065461 002 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2009/08/10 SANDOZ
090509 002 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2010/05/12 DR REDDYS LABS LTD
090596 002 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2010/09/17 MYLAN
090802 002 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2012/09/28 PANACEA
090687 002 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2014/07/22 STRIDES PHARMA
206651 002 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2017/11/30 BELCHER
206662 002 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2020/11/10 GLENMARK PHARMS LTD
212297 002 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2020/11/10 BIOCON PHARMA
213112 002 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2020/11/10 CONCORD BIOTECH LTD
203740 002 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2020/11/12 ALKEM LABS LTD
210929 002 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2023/04/17 HANGZHOU ZHONGMEI
活性成分:TACROLIMUS 剂型/给药途径:CAPSULE;ORAL 规格:EQ 5MG 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
050708 002 NDA PROGRAF TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription Yes Yes AB 1994/04/08 ASTELLAS
065461 003 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2009/08/10 SANDOZ
090509 003 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2010/05/12 DR REDDYS LABS LTD
090596 003 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2010/09/17 MYLAN
090802 003 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2012/09/28 PANACEA
090687 003 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2014/07/22 STRIDES PHARMA
206651 003 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2017/11/30 BELCHER
206662 003 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2020/11/10 GLENMARK PHARMS LTD
212297 003 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2020/11/10 BIOCON PHARMA
213112 003 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2020/11/10 CONCORD BIOTECH LTD
203740 003 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2020/11/12 ALKEM LABS LTD
210929 003 ANDA TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2023/04/17 HANGZHOU ZHONGMEI
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