药品注册申请号:017486
申请类型:NDA (新药申请)
申请人:EPIC PHARMA LLC
申请人全名:EPIC PHARMA LLC
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 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML No No None 1975/12/10 Approved Prior to Jan 1, 1982 Discontinued
002 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
003 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
004 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 20,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
005 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 40,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
1996/03/27 SUPPL-12(补充) Approval Labeling
1996/03/27 SUPPL-4(补充) Approval Labeling
1996/03/27 SUPPL-3(补充) Approval Labeling
1988/01/25 SUPPL-9(补充) Approval Labeling
1980/11/13 SUPPL-7(补充) Approval Labeling
1978/12/06 SUPPL-5(补充) Approval Labeling
1975/12/10 ORIG-1(原始申请) 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)
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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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