药品注册申请号:077006
申请类型:ANDA (仿制药申请)
申请人:IVAX SUB TEVA PHARMS
申请人全名:IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
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 TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG No No AB 2015/02/23 2015/02/23 Prescription
002 TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG No No AB 2015/02/23 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
2015/09/25 SUPPL-1(补充) Approval Manufacturing (CMC) UNKNOWN
2015/02/23 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:TOLTERODINE TARTRATE 剂型/给药途径:TABLET;ORAL 规格:1MG 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
020771 001 NDA DETROL TOLTERODINE TARTRATE TABLET;ORAL 1MG Prescription Yes No AB 1998/03/25 UPJOHN
077006 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG Prescription No No AB 2015/02/23 IVAX SUB TEVA PHARMS
203409 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG Prescription No No AB 2015/08/31 MACLEODS PHARMS LTD
210775 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG Prescription No No AB 2019/12/30 ELYSIUM
204721 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG Prescription No No AB 2020/01/24 UNIQUE
205399 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG Prescription No No AB 2020/08/05 UNICHEM
204397 001 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 1MG Prescription No No AB 2021/08/02 HETERO LABS LTD V
活性成分:TOLTERODINE TARTRATE 剂型/给药途径:TABLET;ORAL 规格:2MG 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
020771 002 NDA DETROL TOLTERODINE TARTRATE TABLET;ORAL 2MG Prescription Yes Yes AB 1998/03/25 UPJOHN
077006 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG Prescription No No AB 2015/02/23 IVAX SUB TEVA PHARMS
203409 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG Prescription No No AB 2015/08/31 MACLEODS PHARMS LTD
210775 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG Prescription No No AB 2019/12/30 ELYSIUM
204721 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG Prescription No No AB 2020/01/24 UNIQUE
205399 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG Prescription No No AB 2020/08/05 UNICHEM
204397 002 ANDA TOLTERODINE TARTRATE TOLTERODINE TARTRATE TABLET;ORAL 2MG Prescription No No AB 2021/08/02 HETERO LABS LTD V
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