药品注册申请号:017422
申请类型:NDA (新药申请)
申请人:EMCURE PHARMS LTD
申请人全名:EMCURE 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 BICNU CARMUSTINE INJECTABLE;INJECTION 100MG/VIAL Yes Yes AP 1977/03/07 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
2017/03/24 SUPPL 55 Approval Labeling STANDARD
2016/04/28 SUPPL 50 Approval Labeling STANDARD
2015/11/25 SUPPL 49 Approval Manufacturing (CMC) STANDARD
2014/06/13 SUPPL 47 Approval Manufacturing (CMC) STANDARD
2013/10/18 SUPPL 46 Approval Labeling STANDARD
2013/09/18 SUPPL 45 Approval Manufacturing (CMC) STANDARD
2011/08/11 SUPPL 42 Approval Labeling UNKNOWN
2011/03/14 SUPPL 38 Approval Labeling STANDARD
2007/08/17 SUPPL 37 Approval Manufacturing (CMC) N/A
2005/10/20 SUPPL 36 Approval Manufacturing (CMC) STANDARD
2003/02/27 SUPPL 35 Approval Labeling STANDARD
1997/09/10 SUPPL 34 Approval Labeling STANDARD
1992/12/11 SUPPL 31 Approval Labeling
1992/07/13 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1991/06/13 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1991/01/03 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1989/09/14 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1989/04/19 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1988/05/17 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1988/01/12 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1987/10/26 SUPPL 22 Approval Labeling
1987/08/07 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1987/04/21 SUPPL 8 Approval Labeling
1987/03/05 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1986/07/11 SUPPL 15 Approval Labeling
1986/05/19 SUPPL 18 Approval Labeling
1986/05/19 SUPPL 17 Approval Labeling
1986/05/19 SUPPL 16 Approval Labeling
1984/12/10 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1984/08/08 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1984/04/03 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1984/03/13 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1984/02/17 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1983/06/29 SUPPL 11 Approval Labeling
1983/02/10 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1982/02/16 SUPPL 7 Approval Labeling
1980/11/12 SUPPL 5 Approval Labeling
1979/10/09 SUPPL 4 Approval Labeling
1979/10/09 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1978/09/15 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1977/12/22 SUPPL 1 Approval Labeling
1977/03/07 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:CARMUSTINE 剂型/给药途径:INJECTABLE;INJECTION 规格:100MG/VIAL 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
017422 001 NDA BICNU CARMUSTINE INJECTABLE;INJECTION 100MG/VIAL Prescription Yes Yes AP Approved Prior to Jan 1, 1982 EMCURE PHARMS LTD
210179 001 ANDA CARMUSTINE CARMUSTINE INJECTABLE;INJECTION 100MG/VIAL Prescription No No AP 2018/09/11 NAVINTA LLC
211229 001 ANDA CARMUSTINE CARMUSTINE INJECTABLE;INJECTION 100MG/VIAL Prescription No No AP 2018/10/16 AMNEAL
209278 001 ANDA CARMUSTINE CARMUSTINE INJECTABLE;INJECTION 100MG/VIAL Prescription No No AP 2019/04/02 STI PHARMA LLC
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