药品注册申请号:050580
申请类型:NDA (新药申请)
申请人:BRISTOL MYERS SQUIBB
申请人全名:BRISTOL MYERS SQUIBB
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 AZACTAM AZTREONAM INJECTABLE;INJECTION 500MG/VIAL No No None 1986/12/31 1986/12/31 Discontinued
002 AZACTAM AZTREONAM INJECTABLE;INJECTION 1GM/VIAL Yes Yes AP 1986/12/31 Prescription
003 AZACTAM AZTREONAM INJECTABLE;INJECTION 2GM/VIAL Yes Yes AP 1986/12/31 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
2018/06/18 SUPPL 44 Approval Labeling STANDARD
2014/09/30 SUPPL 43 Approval Manufacturing (CMC) PRIORITY
2013/06/17 SUPPL 42 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2008/01/22 SUPPL 40 Approval Labeling STANDARD
2004/12/16 SUPPL 37 Approval Labeling STANDARD
2002/11/27 SUPPL 36 Approval Manufacturing (CMC) PRIORITY
2002/09/13 SUPPL 35 Approval Manufacturing (CMC) PRIORITY
2002/06/24 SUPPL 34 Approval Manufacturing (CMC) PRIORITY
2002/03/25 SUPPL 33 Approval Labeling STANDARD
1999/12/29 SUPPL 32 Approval Manufacturing (CMC) PRIORITY
1999/02/16 SUPPL 31 Approval Labeling STANDARD
1999/02/16 SUPPL 28 Approval Labeling STANDARD
1998/07/28 SUPPL 27 Approval Manufacturing (CMC) PRIORITY
1997/11/07 SUPPL 30 Approval Manufacturing (CMC) PRIORITY
1997/06/12 SUPPL 29 Approval Manufacturing (CMC) PRIORITY
1996/11/01 SUPPL 8 Approval Efficacy
1996/08/20 SUPPL 22 Approval Labeling
1996/08/20 SUPPL 21 Approval Labeling
1996/04/03 SUPPL 26 Approval Manufacturing (CMC) PRIORITY
1994/05/23 SUPPL 25 Approval Manufacturing (CMC) PRIORITY
1994/05/23 SUPPL 23 Approval Manufacturing (CMC) PRIORITY
1993/02/18 SUPPL 24 Approval Manufacturing (CMC) PRIORITY
1992/06/25 SUPPL 19 Approval Labeling
1991/09/30 SUPPL 20 Approval Labeling
1990/09/18 SUPPL 17 Approval Manufacturing (CMC) PRIORITY
1989/04/10 SUPPL 18 Approval Manufacturing (CMC) PRIORITY
1986/12/31 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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:AZTREONAM 剂型/给药途径:INJECTABLE;INJECTION 规格:1GM/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
050580 002 NDA AZACTAM AZTREONAM INJECTABLE;INJECTION 1GM/VIAL Prescription Yes Yes AP 1986/12/31 BRISTOL MYERS SQUIBB
065439 002 ANDA AZTREONAM AZTREONAM INJECTABLE;INJECTION 1GM/VIAL Prescription No No AP 2010/06/18 FRESENIUS KABI USA
活性成分:AZTREONAM 剂型/给药途径:INJECTABLE;INJECTION 规格:2GM/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
050580 003 NDA AZACTAM AZTREONAM INJECTABLE;INJECTION 2GM/VIAL Prescription Yes Yes AP 1986/12/31 BRISTOL MYERS SQUIBB
065439 003 ANDA AZTREONAM AZTREONAM INJECTABLE;INJECTION 2GM/VIAL Prescription No No AP 2010/06/18 FRESENIUS KABI USA
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