药品注册申请号:050545
申请类型:NDA (新药申请)
申请人:WYETH PHARMS INC
申请人全名:WYETH PHARMACEUTICALS 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
002 PIPRACIL PIPERACILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1981/12/29 Approved Prior to Jan 1, 1982 Discontinued
003 PIPRACIL PIPERACILLIN SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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 PIPRACIL PIPERACILLIN SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
006 PIPRACIL PIPERACILLIN SODIUM INJECTABLE;INJECTION EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1985/09/30 Discontinued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
2008/04/17 SUPPL-53(补充) Approval Labeling STANDARD
2005/07/27 SUPPL-52(补充) Approval Labeling STANDARD
2005/07/27 SUPPL-51(补充) Approval Labeling STANDARD
2004/04/02 SUPPL-50(补充) Approval Labeling STANDARD
2003/05/22 SUPPL-37(补充) Approval Labeling STANDARD
2003/05/22 SUPPL-33(补充) Approval Labeling STANDARD
2003/05/22 SUPPL-31(补充) Approval Labeling
2002/12/02 SUPPL-46(补充) Approval Manufacturing (CMC) PRIORITY
2002/10/10 SUPPL-45(补充) Approval Manufacturing (CMC) PRIORITY
2002/02/26 SUPPL-43(补充) Approval Manufacturing (CMC) PRIORITY
2002/02/01 SUPPL-42(补充) Approval Labeling STANDARD
2001/08/20 SUPPL-39(补充) Approval Manufacturing (CMC) PRIORITY
2000/11/22 SUPPL-36(补充) Approval Manufacturing (CMC) PRIORITY
1999/03/11 SUPPL-34(补充) Approval Manufacturing (CMC) PRIORITY
1998/07/13 SUPPL-35(补充) Approval Manufacturing (CMC) PRIORITY
1991/09/20 SUPPL-29(补充) Approval Manufacturing (CMC) PRIORITY
1989/10/04 SUPPL-28(补充) Approval Manufacturing (CMC) PRIORITY
1989/03/30 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1988/05/13 SUPPL-27(补充) Approval Labeling
1988/05/03 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
1987/12/22 SUPPL-25(补充) Approval Labeling
1987/10/06 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
1987/09/25 SUPPL-24(补充) Approval Labeling
1987/07/22 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
1987/05/27 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
1987/04/08 SUPPL-20(补充) Approval Labeling
1986/08/15 SUPPL-18(补充) Approval Labeling
1985/09/30 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1985/06/19 SUPPL-14(补充) Approval Labeling
1985/06/03 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1985/05/31 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1985/01/30 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1984/08/23 SUPPL-11(补充) Approval Labeling
1984/08/06 SUPPL-8(补充) Approval Efficacy
1984/08/06 SUPPL-1(补充) Approval Efficacy
1984/08/01 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1983/07/05 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
1983/03/18 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
1983/03/01 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1981/12/29 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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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