药品注册申请号:076999
申请类型:ANDA (仿制药申请)
申请人:TEVA
申请人全名:TEVA 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 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE No No AB 2012/05/17 2012/05/17 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
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
2020/03/24 SUPPL-14(补充) Approval Labeling STANDARD
2020/03/24 SUPPL-13(补充) Approval Labeling STANDARD
2020/03/24 SUPPL-12(补充) Approval Labeling STANDARD
2020/03/24 SUPPL-11(补充) Approval Labeling STANDARD
2020/03/24 SUPPL-10(补充) Approval Labeling STANDARD
2015/10/28 SUPPL-7(补充) Approval Labeling STANDARD
2015/03/09 SUPPL-6(补充) Approval Labeling STANDARD
2015/03/09 SUPPL-3(补充) Approval Labeling STANDARD
2015/03/09 SUPPL-2(补充) Approval Labeling STANDARD
2012/05/17 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
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
与本品治疗等效的药品
活性成分:CLOPIDOGREL BISULFATE 剂型/给药途径:TABLET;ORAL 规格:EQ 75MG 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
020839 001 NDA PLAVIX CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription Yes No AB 1997/11/17 SANOFI AVENTIS US
076273 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2008/01/14 DR REDDYS
076274 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2012/05/17 APOTEX INC
076999 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2012/05/17 TEVA
078004 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2012/05/17 ACME LABS
090494 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Discontinued No No AB 2012/05/17 SUN PHARM
090540 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2012/05/17 AUROBINDO PHARMA LTD
090844 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2012/05/17 TORRENT PHARMS LTD
202925 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Discontinued No No AB 2013/03/27 ACCORD HLTHCARE
202928 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2014/02/10 MACLEODS PHARMS LTD
203751 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2014/04/11 AMNEAL PHARMS
204165 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2014/09/15 SCIEGEN PHARMS INC
204359 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2017/02/02 RISING
206376 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2018/05/07 PRINSTON INC
213351 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2020/07/17 POLYGEN PHARMS
205345 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2023/08/04 HETERO LABS LTD V
203632 001 ANDA CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2023/12/08 ALKEM LABS LTD
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