药品注册申请号:204431
申请类型:ANDA (仿制药申请)
申请人:ETHYPHARM USA CORP
申请人全名:ETHYPHARM USA CORP
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 AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE No No AB 2015/10/16 2015/10/16 Prescription
002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE No No AB 2015/10/16 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 17 Approval Labeling STANDARD
2018/10/31 SUPPL 14 Approval REMS
2018/02/01 SUPPL 13 Approval Labeling STANDARD
2018/01/31 SUPPL 11 Approval Labeling STANDARD
2017/05/23 SUPPL 12 Approval REMS
2016/12/16 SUPPL 7 Approval Labeling STANDARD
2016/12/16 SUPPL 6 Approval Labeling STANDARD
2016/10/31 SUPPL 9 Approval Manufacturing (CMC) UNKNOWN
2016/07/07 SUPPL 5 Approval REMS
2015/10/16 ORIG 1 Approval STANDARD
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; NALOXONE HYDROCHLORIDE 剂型/给药途径:TABLET;SUBLINGUAL 规格:EQ 2MG BASE;EQ 0.5MG 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
203136 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2013/02/22 AMNEAL PHARMS
091422 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2013/02/22 ACTAVIS ELIZABETH
203326 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2014/06/27 HIKMA
204431 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2015/10/16 ETHYPHARM USA CORP
201633 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2016/08/05 SUN PHARM
205022 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2016/09/19 LANNETT CO INC
207000 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2017/12/13 SPECGX LLC
205601 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2020/03/30 RHODES PHARMS
活性成分:BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 剂型/给药途径:TABLET;SUBLINGUAL 规格:EQ 8MG BASE;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
203136 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2013/02/22 AMNEAL PHARMS
091422 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No Yes AB 2013/02/22 ACTAVIS ELIZABETH
203326 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2014/06/27 HIKMA
204431 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2015/10/16 ETHYPHARM USA CORP
201633 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2016/08/05 SUN PHARM
205022 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2016/09/19 LANNETT CO INC
207000 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2017/12/13 SPECGX LLC
205601 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2020/03/30 RHODES PHARMS
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