药品注册申请号：209403
申请类型：ANDA (仿制药申请)
申请人：HETERO LABS LTD V
申请人全名：HETERO LABS LTD UNIT V
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 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE No No AB 2020/10/07 2020/10/07 Prescription
002 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE No No AB 2020/10/07 Prescription
003 CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE No No AB 2020/10/07 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
2020/10/07 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:CINACALCET HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 30MG 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
208971 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE None (Tentative Approval) No No AB -- ZYDUS PHARMS USA INC
021688 001 NDA SENSIPAR CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Discontinued Yes No AB 2004/03/08 AMGEN
206125 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2018/03/08 AUROBINDO PHARMA LTD
208915 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2018/03/08 CIPLA
209226 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2018/04/30 STRIDES PHARMA
210207 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2018/08/01 SLATE RUN PHARMA
207008 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Discontinued No No AB 2018/10/11 SUN PHARM
204377 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2018/12/27 WATSON LABS TEVA
210570 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2019/05/17 ALKEM LABS LTD
211892 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2020/05/15 ACCORD HLTHCARE
213325 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2020/05/18 CHARTWELL RX
208368 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2020/09/18 DR REDDYS
209403 001 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Prescription No No AB 2020/10/07 HETERO LABS LTD V
活性成分:CINACALCET HYDROCHLORIDE 剂型/给药途径:TABLET;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
208971 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE None (Tentative Approval) No No AB -- ZYDUS PHARMS USA INC
021688 002 NDA SENSIPAR CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Discontinued Yes No AB 2004/03/08 AMGEN
206125 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Prescription No No AB 2018/03/08 AUROBINDO PHARMA LTD
208915 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Prescription No No AB 2018/03/08 CIPLA
209226 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Prescription No No AB 2018/04/30 STRIDES PHARMA
210207 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Prescription No No AB 2018/08/01 SLATE RUN PHARMA
207008 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Prescription No No AB 2018/10/11 SUN PHARM
204377 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Prescription No No AB 2018/12/27 WATSON LABS TEVA
210570 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Prescription No No AB 2019/05/17 ALKEM LABS LTD
211892 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Prescription No No AB 2020/05/15 ACCORD HLTHCARE
213325 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Prescription No No AB 2020/05/18 CHARTWELL RX
208368 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Prescription No No AB 2020/09/18 DR REDDYS
209403 002 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 60MG BASE Prescription No No AB 2020/10/07 HETERO LABS LTD V
活性成分:CINACALCET HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 90MG 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
208971 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE None (Tentative Approval) No No AB -- ZYDUS PHARMS USA INC
021688 003 NDA SENSIPAR CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Discontinued Yes No AB 2004/03/08 AMGEN
206125 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Prescription No No AB 2018/03/08 AUROBINDO PHARMA LTD
208915 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Prescription No No AB 2018/03/08 CIPLA
209226 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Prescription No Yes AB 2018/04/30 STRIDES PHARMA
210207 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Prescription No No AB 2018/08/01 SLATE RUN PHARMA
207008 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Discontinued No No AB 2018/10/11 SUN PHARM
204377 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Prescription No No AB 2018/12/27 WATSON LABS TEVA
210570 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Prescription No No AB 2019/05/17 ALKEM LABS LTD
211892 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Prescription No No AB 2020/05/15 ACCORD HLTHCARE
213325 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Prescription No No AB 2020/05/18 CHARTWELL RX
208368 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Prescription No No AB 2020/09/18 DR REDDYS
209403 003 ANDA CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE TABLET;ORAL EQ 90MG BASE Prescription No No AB 2020/10/07 HETERO LABS LTD V
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药品NDC数据与药品包装、标签说明书
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