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 | RLD | RS | TE 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 |
Prescription |
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 | RLD | RS | TE 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 |
Prescription |
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 | RLD | RS | TE 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 |
Prescription |
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 |