药品注册申请号:202396
申请类型:ANDA (仿制药申请)
申请人:MYLAN
申请人全名:MYLAN PHARMACEUTICALS INC
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 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG No No AB 2018/11/28 2018/11/28 Prescription
002 LANSOPRAZOLE LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG No No AB 2018/11/28 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
2024/05/03 SUPPL-6(补充) Approval Labeling STANDARD
2024/05/03 SUPPL-4(补充) Approval Labeling STANDARD
2024/05/03 SUPPL-3(补充) Approval Labeling STANDARD
2021/11/12 SUPPL-2(补充) Approval Labeling STANDARD
2018/11/28 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:LANSOPRAZOLE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;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
021428 001 NDA PREVACID LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG Prescription Yes No AB 2002/08/30 TAKEDA PHARMS USA
208784 001 ANDA LANSOPRAZOLE LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG Prescription No No AB 2017/09/21 TEVA PHARMS USA
200816 001 ANDA LANSOPRAZOLE LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG Prescription No No AB 2018/11/27 ZYDUS PHARMS
202396 001 ANDA LANSOPRAZOLE LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG Prescription No No AB 2018/11/28 MYLAN
210465 001 ANDA LANSOPRAZOLE LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG Prescription No No AB 2021/02/01 DR REDDYS
207167 001 ANDA LANSOPRAZOLE LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 15MG Prescription No No AB 2023/03/28 AUROBINDO PHARMA LTD
活性成分:LANSOPRAZOLE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;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
021428 002 NDA PREVACID LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG Prescription Yes Yes AB 2002/08/30 TAKEDA PHARMS USA
208784 002 ANDA LANSOPRAZOLE LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG Prescription No No AB 2017/09/21 TEVA PHARMS USA
200816 002 ANDA LANSOPRAZOLE LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG Prescription No No AB 2018/11/27 ZYDUS PHARMS
202396 002 ANDA LANSOPRAZOLE LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG Prescription No No AB 2018/11/28 MYLAN
210465 002 ANDA LANSOPRAZOLE LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG Prescription No No AB 2021/02/01 DR REDDYS
207167 002 ANDA LANSOPRAZOLE LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 30MG Prescription No No AB 2023/03/28 AUROBINDO PHARMA LTD
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