药品注册申请号:012223
申请类型:NDA (新药申请)
申请人:TELIGENT
申请人全名:TELIGENT OU
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 AQUAMEPHYTON PHYTONADIONE INJECTABLE;INJECTION 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1960/06/28 Approved Prior to Jan 1, 1982 Discontinued
002 AQUAMEPHYTON PHYTONADIONE INJECTABLE;INJECTION 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
2018/11/23 SUPPL 42 Approval Labeling STANDARD
2018/03/07 SUPPL 41 Approval Labeling STANDARD
2017/05/25 SUPPL 40 Approval Labeling STANDARD
2003/06/04 SUPPL 39 Approval Labeling STANDARD
2003/02/27 SUPPL 38 Approval Labeling STANDARD
2001/08/16 SUPPL 37 Approval Manufacturing (CMC) STANDARD
2001/05/18 SUPPL 36 Approval Labeling STANDARD
1998/07/14 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1998/05/28 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1997/01/14 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1996/12/06 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1996/12/06 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1996/06/25 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1995/12/05 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1995/06/08 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1995/04/24 SUPPL 27 Approval Labeling STANDARD
1991/06/28 SUPPL 26 Approval Labeling
1990/04/26 SUPPL 25 Approval Labeling
1986/08/19 SUPPL 21 Approval Labeling
1985/08/27 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1984/10/11 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1982/08/18 SUPPL 22 Approval Labeling
1981/11/03 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1981/07/14 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1980/11/28 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1979/09/18 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1976/09/01 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1960/06/28 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer 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
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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