药品注册申请号:019655
申请类型:NDA (新药申请)
申请人:VIIV HLTHCARE
申请人全名:VIIV HEALTHCARE CO
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 RETROVIR ZIDOVUDINE CAPSULE;ORAL 100MG Yes Yes AB 1987/03/19 1987/03/19 Prescription
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
2020/06/18 SUPPL-59(补充) Approval Labeling STANDARD
2018/09/10 SUPPL-58(补充) Approval Labeling STANDARD
2017/11/28 SUPPL-57(补充) Approval Labeling STANDARD
2017/04/10 SUPPL-56(补充) Approval Labeling STANDARD
2017/02/24 SUPPL-55(补充) Approval Labeling STANDARD
2014/12/23 SUPPL-54(补充) Approval Labeling STANDARD
2012/05/31 SUPPL-53(补充) Approval Labeling STANDARD
2011/11/18 SUPPL-52(补充) Approval Labeling 901 REQUIRED
2010/05/17 SUPPL-49(补充) Approval Labeling STANDARD
2009/11/06 SUPPL-48(补充) Approval Labeling STANDARD
2008/09/19 SUPPL-46(补充) Approval Efficacy UNKNOWN
2006/11/15 SUPPL-43(补充) Approval Labeling STANDARD
2006/05/10 SUPPL-41(补充) Approval Labeling STANDARD
2003/10/15 SUPPL-39(补充) Approval Labeling STANDARD
2002/12/18 SUPPL-38(补充) Approval Labeling STANDARD
2002/02/21 SUPPL-37(补充) Approval Labeling STANDARD
2001/10/05 SUPPL-36(补充) Approval Labeling STANDARD
2001/03/30 SUPPL-32(补充) Approval Labeling STANDARD
2000/02/01 SUPPL-35(补充) Approval Manufacturing (CMC)
1999/02/26 SUPPL-34(补充) Approval Manufacturing (CMC)
1998/12/28 SUPPL-33(补充) Approval Manufacturing (CMC)
1998/03/04 SUPPL-30(补充) Approval Labeling STANDARD
1997/11/04 SUPPL-31(补充) Approval Manufacturing (CMC)
1996/10/04 SUPPL-29(补充) Approval Efficacy STANDARD
1996/10/04 SUPPL-26(补充) Approval Efficacy UNKNOWN
1995/07/20 SUPPL-27(补充) Approval Labeling STANDARD
1995/02/06 SUPPL-25(补充) Approval Manufacturing (CMC)
1994/10/07 SUPPL-24(补充) Approval Labeling STANDARD
1994/08/08 SUPPL-23(补充) Approval Efficacy PRIORITY
1994/08/08 SUPPL-20(补充) Approval Labeling
1993/08/24 SUPPL-22(补充) Approval Labeling STANDARD
1993/08/24 SUPPL-12(补充) Approval Labeling
1993/08/24 SUPPL-3(补充) Approval Labeling
1990/05/02 SUPPL-15(补充) Approval Labeling
1990/04/30 SUPPL-14(补充) Approval Manufacturing (CMC)
1990/03/02 SUPPL-11(补充) Approval Labeling
1990/01/12 SUPPL-13(补充) Approval Efficacy
1989/03/13 SUPPL-9(补充) Approval Manufacturing (CMC)
1989/03/06 SUPPL-8(补充) Approval Manufacturing (CMC)
1988/10/13 SUPPL-5(补充) Approval Manufacturing (CMC)
1987/04/21 SUPPL-1(补充) Approval Manufacturing (CMC) ;Orphan
1987/03/19 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY ;Orphan
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
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
活性成分:ZIDOVUDINE 剂型/给药途径:CAPSULE;ORAL 规格:100MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
019655 001 NDA RETROVIR ZIDOVUDINE CAPSULE;ORAL 100MG Prescription Yes Yes AB 1987/03/19 VIIV HLTHCARE
078128 001 ANDA ZIDOVUDINE ZIDOVUDINE CAPSULE;ORAL 100MG Prescription No No AB 2006/03/27 AUROBINDO PHARMA LTD
078349 001 ANDA ZIDOVUDINE ZIDOVUDINE CAPSULE;ORAL 100MG Prescription No No AB 2007/05/23 CIPLA LTD
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database