药品注册申请号:050461
申请类型:NDA (新药申请)
申请人:GLAXOSMITHKLINE
申请人全名:GLAXOSMITHKLINE
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 ANCEF CEFAZOLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1973/10/04 Approved Prior to Jan 1, 1982 Discontinued
002 ANCEF CEFAZOLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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 ANCEF CEFAZOLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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 ANCEF CEFAZOLIN SODIUM INJECTABLE;INJECTION EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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 ANCEF CEFAZOLIN SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
2005/01/06 SUPPL-138(补充) Approval Labeling STANDARD
2004/06/02 SUPPL-139(补充) Approval Labeling STANDARD
2004/01/15 SUPPL-135(补充) Approval Labeling STANDARD
2002/05/21 SUPPL-134(补充) Approval Manufacturing (CMC)
1999/07/29 SUPPL-133(补充) Approval Labeling STANDARD
1994/01/04 SUPPL-132(补充) Approval Manufacturing (CMC)
1992/07/14 SUPPL-130(补充) Approval Labeling
1992/06/22 SUPPL-50(补充) Approval Manufacturing (CMC)
1992/05/29 SUPPL-129(补充) Approval Manufacturing (CMC)
1992/03/12 SUPPL-45(补充) Approval Manufacturing (CMC)
1992/01/28 SUPPL-44(补充) Approval Manufacturing (CMC)
1991/06/28 SUPPL-48(补充) Approval Manufacturing (CMC)
1990/02/14 SUPPL-43(补充) Approval Manufacturing (CMC)
1982/09/20 SUPPL-128(补充) Approval Labeling
1982/07/12 SUPPL-127(补充) Approval Labeling
1982/07/12 SUPPL-126(补充) Approval Labeling
1982/06/28 SUPPL-125(补充) Approval Labeling
1982/06/04 SUPPL-124(补充) Approval Labeling
1982/05/18 SUPPL-123(补充) Approval Labeling
1982/05/12 SUPPL-122(补充) Approval Labeling
1982/05/05 SUPPL-121(补充) Approval Labeling
1982/04/20 SUPPL-120(补充) Approval Labeling
1982/03/08 SUPPL-119(补充) Approval Labeling
1982/02/19 SUPPL-118(补充) Approval Labeling
1982/01/04 SUPPL-117(补充) Approval Labeling
1981/11/27 SUPPL-116(补充) Approval Manufacturing (CMC)
1981/09/03 SUPPL-115(补充) Approval Labeling
1981/09/01 SUPPL-114(补充) Approval Labeling
1981/08/11 SUPPL-113(补充) Approval Labeling
1981/07/23 SUPPL-112(补充) Approval Labeling
1981/06/19 SUPPL-109(补充) Approval Labeling
1981/06/10 SUPPL-111(补充) Approval Labeling
1981/04/08 SUPPL-110(补充) Approval Labeling
1981/03/12 SUPPL-108(补充) Approval Labeling
1981/02/11 SUPPL-107(补充) Approval Labeling
1981/01/27 SUPPL-106(补充) Approval Labeling
1980/07/17 SUPPL-105(补充) Approval Labeling
1980/03/05 SUPPL-104(补充) Approval Manufacturing (CMC)
1980/02/26 SUPPL-103(补充) Approval Labeling
1979/05/15 SUPPL-101(补充) Approval Manufacturing (CMC)
1979/02/23 SUPPL-99(补充) Approval Manufacturing (CMC)
1978/11/28 SUPPL-98(补充) Approval Manufacturing (CMC)
1978/11/14 SUPPL-97(补充) Approval Labeling
1978/10/18 SUPPL-96(补充) Approval Labeling
1978/09/29 SUPPL-95(补充) Approval Labeling
1978/08/28 SUPPL-94(补充) Approval Labeling
1978/08/22 SUPPL-93(补充) Approval Labeling
1978/08/17 SUPPL-92(补充) Approval Labeling
1978/08/10 SUPPL-91(补充) Approval Labeling
1978/07/25 SUPPL-90(补充) Approval Labeling
1978/05/23 SUPPL-89(补充) Approval Labeling
1978/05/23 SUPPL-88(补充) Approval Manufacturing (CMC)
1978/05/22 SUPPL-83(补充) Approval Labeling
1978/04/06 SUPPL-87(补充) Approval Manufacturing (CMC)
1977/12/15 SUPPL-86(补充) Approval Labeling
1977/10/14 SUPPL-85(补充) Approval Labeling
1977/06/09 SUPPL-84(补充) Approval Labeling
1977/06/08 SUPPL-65(补充) Approval Labeling
1976/10/08 SUPPL-82(补充) Approval Labeling
1976/08/12 SUPPL-81(补充) Approval Labeling
1976/08/05 SUPPL-80(补充) Approval Labeling
1976/07/08 SUPPL-79(补充) Approval Manufacturing (CMC)
1976/06/16 SUPPL-78(补充) Approval Labeling
1976/06/08 SUPPL-77(补充) Approval Labeling
1976/05/10 SUPPL-76(补充) Approval Manufacturing (CMC)
1976/05/06 SUPPL-75(补充) Approval Manufacturing (CMC)
1976/03/15 SUPPL-74(补充) Approval Manufacturing (CMC)
1976/03/15 SUPPL-73(补充) Approval Manufacturing (CMC)
1976/03/01 SUPPL-72(补充) Approval Manufacturing (CMC)
1976/02/26 SUPPL-71(补充) Approval Labeling
1976/02/26 SUPPL-70(补充) Approval Labeling
1975/11/20 SUPPL-69(补充) Approval Manufacturing (CMC)
1975/11/20 SUPPL-68(补充) Approval Manufacturing (CMC)
1975/09/18 SUPPL-67(补充) Approval Manufacturing (CMC)
1975/09/10 SUPPL-66(补充) Approval Labeling
1975/07/07 SUPPL-64(补充) Approval Labeling
1975/05/12 SUPPL-63(补充) Approval Labeling
1975/04/29 SUPPL-62(补充) Approval Labeling
1975/04/10 SUPPL-61(补充) Approval Labeling
1975/04/10 SUPPL-60(补充) Approval Labeling
1975/02/25 SUPPL-59(补充) Approval Labeling
1975/02/18 SUPPL-58(补充) Approval Labeling
1974/12/24 SUPPL-57(补充) Approval Labeling
1974/10/03 SUPPL-53(补充) Approval Labeling
1974/09/26 SUPPL-56(补充) Approval Labeling
1974/09/26 SUPPL-55(补充) Approval Manufacturing (CMC)
1974/06/26 SUPPL-54(补充) Approval Manufacturing (CMC)
1974/03/15 SUPPL-52(补充) Approval Manufacturing (CMC)
1974/01/23 SUPPL-51(补充) Approval Labeling
1973/10/04 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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