药品注册申请号:202294
申请类型:ANDA (仿制药申请)
申请人:ENDO OPERATIONS
申请人全名:ENDO OPERATIONS 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 DEXLANSOPRAZOLE DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE;ORAL 60MG No No AB 2017/04/19 2017/04/19 Prescription
002 DEXLANSOPRAZOLE DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE;ORAL 30MG No No AB 2022/06/16 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
2022/08/03 SUPPL-9(补充) Approval Labeling STANDARD
2022/06/16 SUPPL-6(补充) Approval Manufacturing (CMC) UNKNOWN
2022/05/03 SUPPL-3(补充) Approval Labeling STANDARD
2022/05/03 SUPPL-2(补充) Approval Labeling STANDARD
2020/10/01 SUPPL-1(补充) Approval Labeling STANDARD
2017/04/19 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:DEXLANSOPRAZOLE 剂型/给药途径:CAPSULE, DELAYED RELEASE;ORAL 规格:60MG 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
022287 002 NDA DEXILANT DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE;ORAL 60MG Prescription Yes Yes AB 2009/01/30 TAKEDA PHARMS USA
202294 001 ANDA DEXLANSOPRAZOLE DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE;ORAL 60MG Prescription No No AB 2017/04/19 ENDO OPERATIONS
202666 002 ANDA DEXLANSOPRAZOLE DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE;ORAL 60MG Prescription No No AB 2022/09/16 TWI PHARMS
205205 002 ANDA DEXLANSOPRAZOLE DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE;ORAL 60MG Prescription No No AB 2024/01/19 MYLAN
活性成分:DEXLANSOPRAZOLE 剂型/给药途径:CAPSULE, 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
022287 001 NDA DEXILANT DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE;ORAL 30MG Prescription Yes No AB 2009/01/30 TAKEDA PHARMS USA
202294 002 ANDA DEXLANSOPRAZOLE DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE;ORAL 30MG Prescription No No AB 2022/06/16 ENDO OPERATIONS
202666 001 ANDA DEXLANSOPRAZOLE DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE;ORAL 30MG Prescription No No AB 2022/09/16 TWI PHARMS
205205 001 ANDA DEXLANSOPRAZOLE DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE;ORAL 30MG Prescription No No AB 2024/01/19 MYLAN
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