药品注册申请号:084051
申请类型:ANDA (仿制药申请)
申请人:SHIRE
申请人全名:SHIRE DEVELOPMENT 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 DEXTROSTAT DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1975/05/29 Approved Prior to Jan 1, 1982 Discontinued
002 DEXTROSTAT DEXTROAMPHETAMINE SULFATE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
2002/11/20 SUPPL-24(补充) Approval Manufacturing (CMC)
2002/01/17 SUPPL-23(补充) Approval Manufacturing (CMC)
2000/02/28 SUPPL-22(补充) Approval Manufacturing (CMC)
2000/01/27 SUPPL-21(补充) Approval Manufacturing (CMC)
1998/10/26 SUPPL-20(补充) Approval Labeling
1998/05/13 SUPPL-18(补充) Approval Labeling
1998/04/15 SUPPL-19(补充) Approval Manufacturing (CMC)
1998/01/09 SUPPL-12(补充) Approval Manufacturing (CMC)
1997/09/26 SUPPL-17(补充) Approval Manufacturing (CMC)
1997/09/26 SUPPL-16(补充) Approval Manufacturing (CMC)
1997/08/18 SUPPL-15(补充) Approval Labeling
1997/08/18 SUPPL-13(补充) Approval Labeling
1997/02/28 SUPPL-14(补充) Approval Manufacturing (CMC)
1995/12/08 SUPPL-11(补充) Approval Manufacturing (CMC)
1995/12/08 SUPPL-10(补充) Approval Manufacturing (CMC)
1990/05/29 SUPPL-9(补充) Approval Labeling
1975/05/29 ORIG-1(原始申请) Approval
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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药品NDC数据与药品包装、标签说明书
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