药品注册申请号:005264
申请类型:NDA (新药申请)
申请人:HOSPIRA
申请人全名:HOSPIRA 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
004 PANHEPRIN HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML No No None 1943/05/04 Approved Prior to Jan 1, 1982 Discontinued
006 PANHEPRIN HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
007 PANHEPRIN HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
008 PANHEPRIN HEPARIN SODIUM INJECTABLE;INJECTION 20,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
009 PANHEPRIN HEPARIN SODIUM INJECTABLE;INJECTION 40,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
010 HEPARIN LOCK FLUSH HEPARIN SODIUM INJECTABLE;INJECTION 100 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
013 HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 2,000 UNITS/ML No No None 1986/04/07 Discontinued
014 HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 2,500 UNITS/ML No No None 1986/04/07 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
2011/12/23 SUPPL 93 Approval Labeling STANDARD
2000/03/21 SUPPL 73 Approval Labeling STANDARD
1998/09/16 SUPPL 70 Approval Labeling STANDARD
1992/10/29 SUPPL 65 Approval Labeling STANDARD
1992/03/24 SUPPL 63 Approval Labeling
1991/07/24 SUPPL 60 Approval Labeling
1988/11/22 SUPPL 58 Approval Labeling
1985/05/21 SUPPL 50 Approval Efficacy
1984/10/04 SUPPL 48 Approval Labeling
1981/10/26 SUPPL 45 Approval Labeling
1981/05/15 SUPPL 42 Approval Efficacy
1981/04/22 SUPPL 43 Approval Labeling
1981/02/18 SUPPL 40 Approval Labeling
1980/09/29 SUPPL 37 Approval Labeling
1980/07/02 SUPPL 39 Approval Labeling
1978/05/15 SUPPL 31 Approval Labeling
1978/01/04 SUPPL 29 Approval Labeling
1977/11/04 SUPPL 27 Approval Labeling
1976/09/22 SUPPL 20 Approval Labeling
1976/09/22 SUPPL 19 Approval Labeling
1976/09/22 SUPPL 18 Approval Labeling
1943/05/04 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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