药品注册申请号:202176
申请类型:ANDA (仿制药申请)
申请人:WOCKHARDT
申请人全名:WOCKHARDT 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 LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG No No AB 2012/09/14 2012/09/14 Prescription
002 LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG No No AB 2012/09/14 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
2019/05/10 SUPPL-8(补充) Approval Labeling STANDARD
2019/05/10 SUPPL-7(补充) Approval Labeling STANDARD
2017/06/01 SUPPL-6(补充) Approval Labeling STANDARD
2017/06/01 SUPPL-3(补充) Approval Labeling STANDARD
2012/09/14 ORIG-1(原始申请) Approval Not Applicable
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:LANSOPRAZOLE 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;ORAL 规格:15MG 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
077255 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2009/11/10 TEVA PHARMS
090763 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2009/11/10 MYLAN PHARMS INC
090331 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2010/04/23 SANDOZ
091269 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2010/10/15 DR REDDYS LABS LTD
202176 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2012/09/14 WOCKHARDT
201921 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2012/12/18 NATCO PHARMA LTD
202366 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2013/08/19 ZYDUS HLTHCARE
202637 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2013/09/13 SUN PHARM
203203 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2016/07/25 XIROMED
205868 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2017/08/30 INVENTIA
207156 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2017/09/28 CHARTWELL MOLECULAR
207394 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2019/01/18 ALKEM LABS LTD
203083 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 15MG Prescription No No AB 2020/05/18 HETERO LABS LTD III
活性成分:LANSOPRAZOLE 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;ORAL 规格:30MG 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
020406 002 NDA PREVACID LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription Yes Yes AB 1995/05/10 TAKEDA PHARMS USA
077255 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2009/11/10 TEVA PHARMS
090763 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2009/11/10 MYLAN PHARMS INC
090331 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2010/04/23 SANDOZ
091269 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2010/10/15 DR REDDYS LABS LTD
202176 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2012/09/14 WOCKHARDT
201921 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2012/12/18 NATCO PHARMA LTD
202366 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2013/08/19 ZYDUS HLTHCARE
091509 001 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2013/09/13 SUN PHARM
203203 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2016/07/25 XIROMED
205868 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2017/08/30 INVENTIA
207156 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2017/09/28 CHARTWELL MOLECULAR
207394 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2019/01/18 ALKEM LABS LTD
203083 002 ANDA LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL 30MG Prescription No No AB 2020/05/18 HETERO LABS LTD III
更多信息
药品NDC数据与药品包装、标签说明书
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