药品注册申请号:090700
申请类型:ANDA (仿制药申请)
申请人:GLENMARK PHARMS LTD
申请人全名:GLENMARK 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 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG No Yes AB 2011/08/03 2011/08/03 Prescription
002 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG No Yes AB 2011/08/03 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
2021/12/22 SUPPL-7(补充) Approval Labeling STANDARD
2019/09/26 SUPPL-6(补充) Approval Labeling STANDARD
2019/09/26 SUPPL-4(补充) Approval Labeling STANDARD
2015/04/09 SUPPL-3(补充) Approval Labeling STANDARD
2015/04/09 SUPPL-2(补充) Approval Labeling STANDARD
2011/08/03 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:VERAPAMIL HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:120MG 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
075072 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 1999/05/25 STRIDES PHARMA
090700 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No Yes AB 2011/08/03 GLENMARK PHARMS LTD
090529 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG Discontinued No No AB 2011/12/30 SUN PHARM INDS INC
206173 003 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 2022/11/14 CADILA PHARMS LTD
活性成分:VERAPAMIL HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:180MG 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
090700 002 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG Prescription No Yes AB 2011/08/03 GLENMARK PHARMS LTD
090529 002 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG Discontinued No No AB 2011/12/30 SUN PHARM INDS INC
206173 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG Prescription No No AB 2017/05/05 CADILA PHARMS LTD
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