药品注册申请号:005521
申请类型:NDA (新药申请)
申请人:LILLY
申请人全名:ELI LILLY AND CO
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 1944/05/19 Approved Prior to Jan 1, 1982 Discontinued
002 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
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
2000/05/23 SUPPL-26(补充) Approval Manufacturing (CMC)
1999/04/27 SUPPL-19(补充) Approval Manufacturing (CMC)
1998/06/05 SUPPL-24(补充) Approval Manufacturing (CMC)
1996/01/31 SUPPL-23(补充) Approval Manufacturing (CMC)
1989/11/29 SUPPL-21(补充) Approval Labeling
1989/10/27 SUPPL-20(补充) Approval Labeling
1989/06/01 SUPPL-18(补充) Approval Labeling
1989/06/01 SUPPL-17(补充) Approval Labeling
1985/05/13 SUPPL-16(补充) Approval Labeling
1982/07/08 SUPPL-11(补充) Approval Manufacturing (CMC)
1981/06/16 SUPPL-15(补充) Approval Manufacturing (CMC)
1981/03/19 SUPPL-14(补充) Approval Manufacturing (CMC)
1980/01/17 SUPPL-12(补充) Approval Labeling
1979/09/07 SUPPL-13(补充) Approval Manufacturing (CMC)
1976/03/18 SUPPL-8(补充) Approval Manufacturing (CMC)
1944/05/19 ORIG-1(原始申请) Approval
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
更多信息
药品NDC数据与药品包装、标签说明书
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