药品注册申请号:018830
申请类型:NDA (新药申请)
申请人:ALVOGEN
申请人全名:ALVOGEN 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001 TAMBOCOR FLECAINIDE ACETATE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1985/10/31 1985/10/31 Discontinued
002 TAMBOCOR FLECAINIDE ACETATE TABLET;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1985/10/31 Discontinued
003 TAMBOCOR FLECAINIDE ACETATE TABLET;ORAL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1988/06/03 Discontinued
004 TAMBOCOR FLECAINIDE ACETATE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1988/08/23 Discontinued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
2016/09/22 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
2000/04/28 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1999/09/03 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1985/10/31 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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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