药品注册申请号:017007
申请类型:NDA (新药申请)
申请人:HIKMA
申请人全名:HIKMA PHARMACEUTICALS 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 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1974/05/28 Approved Prior to Jan 1, 1982 Discontinued
002 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 7,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
005 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 15,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
006 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 20,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
007 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 2,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
008 HEPARIN LOCK FLUSH HEPARIN SODIUM INJECTABLE; INJECTION 10 UNITS/ML No No None -- Discontinued
009 HEPARIN LOCK FLUSH HEPARIN SODIUM INJECTABLE; INJECTION 100 UNITS/ML No No None -- Discontinued
010 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
2024/10/24 SUPPL-40(补充) Approval Labeling STANDARD
2018/03/27 SUPPL-39(补充) Approval Labeling STANDARD
2000/09/06 SUPPL-38(补充) Approval Labeling STANDARD
1997/03/05 SUPPL-36(补充) Approval Labeling STANDARD
1996/05/20 SUPPL-35(补充) Approval Manufacturing (CMC) PRIORITY
1993/10/20 SUPPL-33(补充) Approval Manufacturing (CMC) PRIORITY
1993/06/14 SUPPL-32(补充) Approval Manufacturing (CMC) PRIORITY
1991/02/28 SUPPL-25(补充) Approval Manufacturing (CMC) PRIORITY
1990/07/20 SUPPL-31(补充) Approval Labeling
1989/07/13 SUPPL-29(补充) Approval Labeling
1989/06/29 SUPPL-28(补充) Approval Labeling
1987/07/29 SUPPL-24(补充) Approval Manufacturing (CMC) PRIORITY
1987/04/14 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
1987/03/05 SUPPL-22(补充) Approval Labeling
1986/04/07 SUPPL-15(补充) Approval Labeling
1983/10/19 SUPPL-19(补充) Approval Labeling
1983/08/29 SUPPL-18(补充) Approval Labeling
1983/05/25 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1982/07/30 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
1981/05/14 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
1980/07/02 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1980/07/02 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1978/10/04 SUPPL-11(补充) Approval Labeling
1978/07/03 SUPPL-10(补充) Approval Labeling
1978/07/03 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1978/02/02 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1978/02/02 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1976/12/29 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1975/12/12 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
1975/10/17 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
1975/03/28 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1974/05/28 ORIG-1(原始申请) Approval Type 3 - New Dosage Form PRIORITY
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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