药品注册申请号：204375
申请类型：ANDA (仿制药申请)
申请人：MACLEODS PHARMS LTD
申请人全名：MACLEODS PHARMACEUTICALS 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 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE No No AB 2017/02/17 2017/02/17 Prescription
002 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE No No AB 2017/02/17 Prescription
003 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE No No AB 2017/02/17 Prescription
004 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE No No AB 2017/02/17 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2017/02/17 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/06/07 SUPPL-25（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert,Labeling-Medication Guide,Labeling-Patient Package Insert STANDARD
2020/09/09 SUPPL-14（补充） Approval Labeling-Patient Package Insert,Labeling-Package Insert STANDARD
2020/09/09 SUPPL-8（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2020/09/09 SUPPL-2（补充） Approval Labeling-Patient Package Insert,Labeling-Package Insert 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:ZIPRASIDONE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 20MG 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
020825 001 NDA GEODON ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription Yes Yes AB 2001/02/05 VIATRIS
077560 001 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB 2012/03/02 LUPIN PHARMS
077561 001 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB 2012/03/02 APOTEX
077565 001 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB 2012/03/02 DR REDDYS LABS INC
077562 001 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB 2012/06/01 SANDOZ INC
090348 001 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB 2012/09/05 CHARTWELL RX
204117 001 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB 2016/12/27 AUROBINDO PHARMA
204375 001 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB 2017/02/17 MACLEODS PHARMS LTD
208988 001 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE Prescription No No AB 2017/08/22 ZYDUS LIFESCIENCES
>>>活性成分:ZIPRASIDONE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 40MG 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
020825 002 NDA GEODON ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription Yes No AB 2001/02/05 VIATRIS
077560 002 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2012/03/02 LUPIN PHARMS
077561 002 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2012/03/02 APOTEX
077565 002 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2012/03/02 DR REDDYS LABS INC
077562 002 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2012/06/01 SANDOZ INC
090348 002 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2012/09/05 CHARTWELL RX
204117 002 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2016/12/27 AUROBINDO PHARMA
204375 002 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2017/02/17 MACLEODS PHARMS LTD
208988 002 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE Prescription No No AB 2017/08/22 ZYDUS LIFESCIENCES
>>>活性成分:ZIPRASIDONE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 60MG 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
020825 003 NDA GEODON ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription Yes No AB 2001/02/05 VIATRIS
077560 003 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2012/03/02 LUPIN PHARMS
077561 003 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2012/03/02 APOTEX
077565 003 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2012/03/02 DR REDDYS LABS INC
077562 003 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2012/06/01 SANDOZ INC
090348 003 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2012/09/05 CHARTWELL RX
204117 003 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2016/12/27 AUROBINDO PHARMA
204375 003 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2017/02/17 MACLEODS PHARMS LTD
208988 003 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 60MG BASE Prescription No No AB 2017/08/22 ZYDUS LIFESCIENCES
>>>活性成分:ZIPRASIDONE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 80MG 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
020825 004 NDA GEODON ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription Yes No AB 2001/02/05 VIATRIS
077560 004 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2012/03/02 LUPIN PHARMS
077561 004 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2012/03/02 APOTEX
077565 004 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2012/03/02 DR REDDYS LABS INC
077562 004 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2012/06/01 SANDOZ INC
090348 004 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2012/09/05 CHARTWELL RX
204117 004 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2016/12/27 AUROBINDO PHARMA
204375 004 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2017/02/17 MACLEODS PHARMS LTD
208988 004 ANDA ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL EQ 80MG BASE Prescription No No AB 2017/08/22 ZYDUS LIFESCIENCES
更多信息
药品NDC数据与药品包装、标签说明书
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