药品注册申请号：000552
申请类型：NDA (新药申请)
申请人：ASPEN GLOBAL INC
申请人全名：ASPEN GLOBAL 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1939/02/09 ORIG-1（原始申请） Approval UNKNOWN
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/10/24 SUPPL-26（补充） Approval Labeling-Package Insert STANDARD
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)-Control
1987/01/06 SUPPL-21（补充） Approval Manufacturing (CMC)-Packaging
1986/07/28 SUPPL-20（补充） Approval Manufacturing (CMC)-Control
1986/04/11 SUPPL-18（补充） Approval Efficacy-New Dosing Regimen
1985/05/13 SUPPL-17（补充） Approval Labeling
1981/06/08 SUPPL-11（补充） Approval Manufacturing (CMC)-Control
1981/03/24 SUPPL-13（补充） Approval Labeling
1980/11/28 SUPPL-15（补充） Approval Manufacturing (CMC)-Control
1980/11/28 SUPPL-14（补充） Approval Manufacturing (CMC)-Control
1978/05/15 SUPPL-10（补充） Approval Manufacturing (CMC)-Control
1978/01/25 SUPPL-12（补充） Approval Labeling
1975/07/28 SUPPL-8（补充） Approval Unspecified
1975/07/28 SUPPL-7（补充） Approval Unspecified
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
无
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
无
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
参考引用1
参考引用2
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