药品注册申请号:000552
申请类型:NDA (新药申请)
申请人:ORGANON USA INC
申请人全名:ORGANON USA 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
001 LIQUAEMIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 20,000 UNITS/ML No No None 1939/02/09 Approved Prior to Jan 1, 1982 Discontinued
002 LIQUAEMIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 40,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
003 LIQUAEMIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
004 LIQUAEMIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
005 LIQUAEMIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
007 LIQUAEMIN LOCK FLUSH HEPARIN SODIUM INJECTABLE;INJECTION 100 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
008 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
009 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
010 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
011 LIQUAEMIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML No No None 1986/04/11 Discontinued
012 LIQUAEMIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML No No None 1986/04/11 Discontinued
013 LIQUAEMIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML No No None 1986/04/11 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
1990/08/02 SUPPL-24(补充) Approval Manufacturing (CMC)
1988/08/05 SUPPL-23(补充) Approval Labeling
1987/12/09 SUPPL-22(补充) Approval Manufacturing (CMC)
1987/01/06 SUPPL-21(补充) Approval Manufacturing (CMC)
1986/07/28 SUPPL-20(补充) Approval Manufacturing (CMC)
1986/04/11 SUPPL-18(补充) Approval Efficacy
1985/05/13 SUPPL-17(补充) Approval Labeling
1981/06/08 SUPPL-11(补充) Approval Manufacturing (CMC)
1981/03/24 SUPPL-13(补充) Approval Labeling
1980/11/28 SUPPL-15(补充) Approval Manufacturing (CMC)
1980/11/28 SUPPL-14(补充) Approval Manufacturing (CMC)
1978/05/15 SUPPL-10(补充) Approval Manufacturing (CMC)
1978/01/25 SUPPL-12(补充) Approval Labeling
1975/07/28 SUPPL-8(补充) Approval REMS
1975/07/28 SUPPL-7(补充) Approval REMS
1939/02/09 ORIG-1(原始申请) Approval UNKNOWN
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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