药品注册申请号:212377
申请类型:ANDA (仿制药申请)
申请人:AUROBINDO PHARMA LTD
申请人全名:AUROBINDO PHARMA 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 PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE TABLET;ORAL 5MG No No AB 2019/08/13 2019/08/13 Prescription
002 PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE TABLET;ORAL 7.5MG No No AB 2019/08/13 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
2019/08/13 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
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:PILOCARPINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:5MG 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
020237 001 NDA SALAGEN PILOCARPINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription Yes No AB 1994/03/22 CONCORDIA
076746 001 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2004/11/16 PADAGIS US
076963 001 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2004/12/22 INNOGENIX
077220 001 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2005/10/14 LANNETT CO INC
077248 001 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2006/03/31 IMPAX LABS
212377 001 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2019/08/13 AUROBINDO PHARMA LTD
活性成分:PILOCARPINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:7.5MG 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
020237 002 NDA SALAGEN PILOCARPINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription Yes Yes AB 2003/04/18 CONCORDIA
077248 002 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2006/03/31 IMPAX LABS
076963 002 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2007/02/27 INNOGENIX
077220 002 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2009/05/06 LANNETT CO INC
212377 002 ANDA PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2019/08/13 AUROBINDO PHARMA LTD
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