药品注册申请号:018401
申请类型:NDA (新药申请)
申请人:INDIVIOR INC
申请人全名:INDIVIOR INC
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 BUPRENEX BUPRENORPHINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 0.3MG BASE/ML Yes Yes AP 1981/12/29 Approved Prior to Jan 1, 1982 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
2019/10/07 SUPPL 25 Approval Labeling STANDARD
2016/12/16 SUPPL 22 Approval Labeling STANDARD
2015/05/11 SUPPL 20 Approval Manufacturing (CMC) STANDARD
2014/02/06 SUPPL 18 Approval Manufacturing (CMC) STANDARD
2013/08/08 SUPPL 19 Approval Manufacturing (CMC) STANDARD
2013/01/04 SUPPL 17 Approval Manufacturing (CMC) STANDARD
2003/06/10 SUPPL 15 Approval Labeling STANDARD
2002/02/11 SUPPL 14 Approval Labeling STANDARD
1995/11/29 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1995/02/13 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1994/04/29 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1993/06/25 SUPPL 11 Approval Labeling STANDARD
1989/12/05 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1989/03/09 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1987/11/19 SUPPL 5 Approval Labeling
1987/02/13 SUPPL 4 Approval Labeling
1985/06/28 SUPPL 1 Approval Labeling
1985/05/17 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1982/10/19 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1981/12/29 ORIG 1 Approval Type 1 - New Molecular Entity 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 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 0.3MG BASE/ML 治疗等效代码:AP
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
018401 001 NDA BUPRENEX BUPRENORPHINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 0.3MG BASE/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 INDIVIOR INC
074137 001 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 0.3MG BASE/ML Prescription No No AP 1996/06/03 HOSPIRA
076931 001 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 0.3MG BASE/ML Prescription No No AP 2005/03/02 WEST-WARD PHARMS INT
078331 001 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 0.3MG BASE/ML Prescription No No AP 2007/03/27 AM REGENT
206586 001 ANDA BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 0.3MG BASE/ML Prescription No No AP 2015/07/28 PAR STERILE PRODUCTS
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2020 DrugFuture->U.S. FDA Drugs Database