药品注册申请号：203657
申请类型：ANDA (仿制药申请)
申请人：ALEMBIC
申请人全名：ALEMBIC 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 GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG No No AA 2018/11/30 2018/11/30 Prescription
002 GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG No No AA 2018/11/30 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2018/11/30 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/08/11 SUPPL-1（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels 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:GLYCOPYRROLATE; 剂型/给药途径:TABLET;ORAL; 规格:1MG; 治疗等效代码:AA<<<
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
012827 001 NDA ROBINUL GLYCOPYRROLATE TABLET;ORAL 1MG Prescription Yes No AA Approved Prior to Jan 1, 1982 CASPER PHARMA LLC
040653 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No Yes AA 2006/08/31 PH HEALTH
040847 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No No AA 2008/03/21 CHARTWELL RX
040821 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No No AA 2008/12/29 RISING
040844 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No No AA 2009/08/18 SUN PHARM INDS LTD
090020 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No No AA 2011/10/19 OXFORD PHARMS
090195 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No No AA 2012/09/21 VELZEN PHARMA PVT
202675 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No No AA 2013/04/15 AUROBINDO PHARMA
091182 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No No AA 2014/02/03 REGCON HOLDINGS
091413 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No No AA 2016/06/20 NATCO
207201 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No No AA 2017/01/03 APPCO
203657 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No No AA 2018/11/30 ALEMBIC
212696 001 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 1MG Prescription No No AA 2024/07/10 QUAGEN
>>>活性成分:GLYCOPYRROLATE; 剂型/给药途径:TABLET;ORAL; 规格:2MG; 治疗等效代码:AA<<<
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
012827 002 NDA ROBINUL FORTE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription Yes No AA Approved Prior to Jan 1, 1982 CASPER PHARMA LLC
040653 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No Yes AA 2006/08/31 PH HEALTH
040847 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No No AA 2008/03/21 CHARTWELL RX
040821 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No No AA 2008/12/29 RISING
040844 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No No AA 2009/08/18 SUN PHARM INDS LTD
090020 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No No AA 2011/10/19 OXFORD PHARMS
090195 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No No AA 2012/09/21 VELZEN PHARMA PVT
091182 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No No AA 2014/02/03 REGCON HOLDINGS
091413 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No No AA 2016/06/20 NATCO
207201 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No No AA 2017/01/03 APPCO
202675 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No No AA 2018/10/30 AUROBINDO PHARMA
203657 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No No AA 2018/11/30 ALEMBIC
212696 002 ANDA GLYCOPYRROLATE GLYCOPYRROLATE TABLET;ORAL 2MG Prescription No No AA 2024/07/10 QUAGEN
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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