药品注册申请号：202949
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 DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE No No AB 2014/06/09 2014/06/09 Prescription
002 DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE No No AB 2014/06/09 Prescription
003 DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE No No AB 2014/06/09 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
2024/02/08 SUPPL-23（补充） Approval Labeling STANDARD
2024/02/08 SUPPL-19（补充） Approval Labeling STANDARD
2024/02/08 SUPPL-16（补充） Approval Labeling STANDARD
2024/02/08 SUPPL-11（补充） Approval Labeling STANDARD
2024/02/08 SUPPL-9（补充） Approval Labeling STANDARD
2024/02/08 SUPPL-8（补充） Approval Labeling STANDARD
2024/02/08 SUPPL-4（补充） Approval Labeling STANDARD
2024/02/08 SUPPL-3（补充） Approval Labeling STANDARD
2024/02/08 SUPPL-2（补充） Approval Labeling STANDARD
2014/06/09 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
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:DULOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;ORAL 规格:EQ 20MG BASE 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
021427 001 NDA CYMBALTA DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription Yes No AB 2004/08/03 LILLY
090694 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2013/12/11 LUPIN LTD
090723 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Discontinued No No AB 2013/12/11 MARKSANS PHARMA
090745 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Discontinued No No AB 2013/12/11 SUN PHARM
090774 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2013/12/11 TORRENT
090778 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2013/12/11 AUROBINDO PHARMA LTD
090776 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2013/12/17 ACTAVIS ELIZABETH
090728 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2014/01/08 ZYDUS PHARMS
090739 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2014/01/08 ZYDUS HLTHCARE
202949 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2014/06/09 ALEMBIC
203088 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2014/06/11 BRECKENRIDGE
202045 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Discontinued No No AB 2014/06/11 APOTEX
203197 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2015/08/26 ALKEM LABS LTD
202336 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2015/10/28 INVENTIA
090780 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Discontinued No No AB 2015/10/28 ENDO OPERATIONS
204343 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2016/08/03 HETERO LABS LTD III
208706 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2017/01/06 AJANTA PHARMA LTD
204815 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2017/03/23 MACLEODS PHARMS LTD
206653 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2017/05/18 PRINSTON INC
211310 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2018/10/16 CSPC OUYI
210599 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2019/04/17 QINGDAO BAHEAL PHARM
212328 001 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 20MG BASE Prescription No No AB 2021/02/11 SUNSHINE
活性成分:DULOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;ORAL 规格:EQ 30MG BASE 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
021427 002 NDA CYMBALTA DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription Yes No AB 2004/08/03 LILLY
090694 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2013/12/11 LUPIN LTD
090723 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Discontinued No No AB 2013/12/11 MARKSANS PHARMA
090745 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Discontinued No No AB 2013/12/11 SUN PHARM
090774 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2013/12/11 TORRENT
090778 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2013/12/11 AUROBINDO PHARMA LTD
090776 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2013/12/17 ACTAVIS ELIZABETH
090728 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2014/01/08 ZYDUS PHARMS
090739 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2014/01/08 ZYDUS HLTHCARE
202949 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2014/06/09 ALEMBIC
203088 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2014/06/11 BRECKENRIDGE
202045 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Discontinued No No AB 2014/06/11 APOTEX
203197 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2015/08/26 ALKEM LABS LTD
202336 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2015/10/28 INVENTIA
090780 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Discontinued No No AB 2015/10/28 ENDO OPERATIONS
204343 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2016/08/03 HETERO LABS LTD III
208706 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2017/01/06 AJANTA PHARMA LTD
204815 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2017/03/23 MACLEODS PHARMS LTD
206653 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2017/05/18 PRINSTON INC
211310 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2018/10/16 CSPC OUYI
210599 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2019/04/17 QINGDAO BAHEAL PHARM
212328 002 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 30MG BASE Prescription No No AB 2021/02/11 SUNSHINE
活性成分:DULOXETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE, DELAYED REL PELLETS;ORAL 规格:EQ 60MG BASE 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
021427 004 NDA CYMBALTA DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription Yes Yes AB 2004/08/03 LILLY
090694 004 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2013/12/11 LUPIN LTD
090723 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Discontinued No No AB 2013/12/11 MARKSANS PHARMA
090745 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Discontinued No No AB 2013/12/11 SUN PHARM
090774 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2013/12/11 TORRENT
090778 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2013/12/11 AUROBINDO PHARMA LTD
090776 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2013/12/17 ACTAVIS ELIZABETH
090728 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2014/01/08 ZYDUS PHARMS
090739 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2014/01/08 ZYDUS HLTHCARE
202949 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2014/06/09 ALEMBIC
203088 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2014/06/11 BRECKENRIDGE
202045 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Discontinued No No AB 2014/06/11 APOTEX
203197 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2015/08/26 ALKEM LABS LTD
202336 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2015/10/28 INVENTIA
090780 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Discontinued No No AB 2015/10/28 ENDO OPERATIONS
204343 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2016/08/03 HETERO LABS LTD III
208706 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2017/01/06 AJANTA PHARMA LTD
204815 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2017/03/23 MACLEODS PHARMS LTD
206653 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2017/05/18 PRINSTON INC
211310 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2018/10/16 CSPC OUYI
210599 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2019/04/17 QINGDAO BAHEAL PHARM
212328 003 ANDA DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL EQ 60MG BASE Prescription No No AB 2021/02/11 SUNSHINE
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