药品注册申请号:050443
申请类型:NDA (新药申请)
申请人:BRISTOL MYERS SQUIBB
申请人全名:BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
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 BLENOXANE BLEOMYCIN SULFATE INJECTABLE;INJECTION EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1973/07/31 Approved Prior to Jan 1, 1982 Discontinued
002 BLENOXANE BLEOMYCIN SULFATE INJECTABLE;INJECTION EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1995/09/07 Discontinued
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
2010/05/10 SUPPL 36 Approval Labeling STANDARD
2004/06/30 SUPPL 27 Approval Labeling STANDARD
2003/03/21 SUPPL 35 Approval Labeling STANDARD
2002/03/20 SUPPL 33 Approval Manufacturing (CMC)
2000/07/03 SUPPL 32 Approval Manufacturing (CMC)
2000/07/03 SUPPL 30 Approval Manufacturing (CMC)
2000/04/12 SUPPL 31 Approval Manufacturing (CMC)
1999/10/20 SUPPL 29 Approval Labeling STANDARD
1999/08/25 SUPPL 28 Approval Labeling STANDARD
1996/09/30 SUPPL 26 Approval Manufacturing (CMC)
1996/02/20 SUPPL 25 Approval Efficacy STANDARD
1995/09/07 SUPPL 24 Approval Manufacturing (CMC)
1994/01/21 SUPPL 22 Approval Manufacturing (CMC)
1994/01/21 SUPPL 21 Approval Manufacturing (CMC)
1994/01/21 SUPPL 19 Approval Manufacturing (CMC)
1994/01/21 SUPPL 17 Approval Manufacturing (CMC)
1993/02/23 SUPPL 23 Approval Labeling STANDARD
1991/01/30 SUPPL 20 Approval Manufacturing (CMC)
1983/10/21 SUPPL 14 Approval Manufacturing (CMC)
1983/10/19 SUPPL 13 Approval Manufacturing (CMC)
1983/09/26 SUPPL 12 Approval Manufacturing (CMC)
1983/04/13 SUPPL 11 Approval Labeling
1982/12/13 SUPPL 10 Approval Manufacturing (CMC)
1976/12/21 SUPPL 9 Approval Labeling
1976/04/05 SUPPL 5 Approval Manufacturing (CMC)
1976/03/31 SUPPL 7 Approval Manufacturing (CMC)
1976/03/15 SUPPL 8 Approval Labeling
1975/10/10 SUPPL 6 Approval Manufacturing (CMC)
1975/10/08 SUPPL 4 Approval Labeling
1975/03/05 SUPPL 3 Approval Manufacturing (CMC)
1974/08/09 SUPPL 2 Approval Labeling
1973/07/31 ORIG 1 Approval Type 1 - New Molecular Entity UNKNOWN
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与本品治疗等效的药品
本品无治疗等效药品
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