药品注册申请号:017064
申请类型:NDA (新药申请)
申请人:DR REDDYS
申请人全名:--
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 LOCK FLUSH HEPARIN SODIUM INJECTABLE; INJECTION 100 UNITS/ML No No None 1974/11/22 -- Discontinued
002 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
003 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
004 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
005 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 20,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
006 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 40,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
015 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 2,500 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
016 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 3,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
017 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 4,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
018 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 6,000 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
019 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 7,500 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
1999/01/27 SUPPL-58(补充) Approval Manufacturing (CMC) STANDARD
1998/05/01 SUPPL-57(补充) Approval Manufacturing (CMC) STANDARD
1996/11/25 SUPPL-56(补充) Approval Manufacturing (CMC) STANDARD
1994/06/29 SUPPL-55(补充) Approval Manufacturing (CMC) STANDARD
1993/11/08 SUPPL-54(补充) Approval Manufacturing (CMC) STANDARD
1993/08/11 SUPPL-51(补充) Approval Manufacturing (CMC) STANDARD
1992/07/28 SUPPL-53(补充) Approval Manufacturing (CMC) STANDARD
1992/07/28 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
1991/10/18 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1991/07/10 SUPPL-50(补充) Approval Labeling
1991/04/23 SUPPL-49(补充) Approval Labeling
1991/04/03 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
1990/02/16 SUPPL-46(补充) Approval Manufacturing (CMC) STANDARD
1990/01/17 SUPPL-45(补充) Approval Labeling
1989/06/14 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1989/06/14 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
1989/06/14 SUPPL-41(补充) Approval Manufacturing (CMC) STANDARD
1989/06/14 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1989/06/14 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
1989/04/28 SUPPL-42(补充) Approval Labeling
1987/11/19 SUPPL-38(补充) Approval Labeling
1987/09/14 SUPPL-37(补充) Approval Labeling
1987/05/22 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
1986/12/19 SUPPL-35(补充) Approval Labeling
1986/04/07 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
1986/01/14 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1985/10/04 SUPPL-32(补充) Approval Labeling
1981/05/26 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1981/03/02 SUPPL-30(补充) Approval Labeling
1978/07/07 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1978/07/07 SUPPL-28(补充) Approval Labeling
1978/07/07 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1978/06/02 SUPPL-26(补充) Approval Labeling
1978/06/02 SUPPL-25(补充) Approval Labeling
1978/04/14 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1977/09/13 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1977/06/29 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1977/06/29 SUPPL-21(补充) Approval REMS STANDARD
1977/02/24 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1977/02/24 SUPPL-16(补充) Approval Labeling
1977/02/24 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1976/04/16 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1976/03/18 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1976/02/24 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1975/12/12 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1974/11/22 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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