药品注册申请号:090622
申请类型:ANDA (仿制药申请)
申请人:ETHYPHARM
申请人全名:ETHYPHARM
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 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE No No AB 2010/09/24 2010/09/24 Prescription
002 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE No No AB 2010/09/24 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/10/09 SUPPL 30 Approval Labeling STANDARD
2018/10/31 SUPPL 26 Approval REMS
2018/02/01 SUPPL 25 Approval Labeling STANDARD
2017/05/23 SUPPL 21 Approval REMS
2016/12/16 SUPPL 19 Approval Labeling STANDARD
2016/12/16 SUPPL 18 Approval Labeling STANDARD
2016/07/07 SUPPL 17 Approval REMS
2015/02/12 SUPPL 12 Approval REMS
2015/02/04 SUPPL 13 Approval Labeling STANDARD
2015/02/04 SUPPL 6 Approval Labeling STANDARD
2013/09/04 SUPPL 7 Approval REMS
2013/02/22 SUPPL 5 Approval Labeling STANDARD
2010/09/24 ORIG 1 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:BUPRENORPHINE HYDROCHLORIDE 剂型/给药途径:TABLET;SUBLINGUAL 规格:EQ 2MG 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
078633 001 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE Prescription No No AB 2009/10/08 HIKMA
090622 001 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE Prescription No No AB 2010/09/24 ETHYPHARM
090819 001 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE Prescription No No AB 2015/02/19 ACTAVIS ELIZABETH
090279 001 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE Prescription No No AB 2015/06/10 CASI PHARMS INC
201760 001 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE Prescription No No AB 2016/01/29 SUN PHARM
207276 001 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE Prescription No No AB 2017/03/27 RHODES PHARMS
活性成分:BUPRENORPHINE HYDROCHLORIDE 剂型/给药途径:TABLET;SUBLINGUAL 规格:EQ 8MG 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
078633 002 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE Prescription No Yes AB 2009/10/08 HIKMA
090622 002 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE Prescription No No AB 2010/09/24 ETHYPHARM
090819 002 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE Prescription No No AB 2015/02/19 ACTAVIS ELIZABETH
090279 002 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE Prescription No No AB 2015/06/10 CASI PHARMS INC
201760 002 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE Prescription No No AB 2016/01/29 SUN PHARM
207276 002 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE Prescription No No AB 2017/03/27 RHODES PHARMS
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