药品注册申请号:019669
申请类型:NDA (新药申请)
申请人:BRISTOL MYERS
申请人全名:BRISTOL MYERS 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 QUESTRAN LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1988/12/05 1988/12/05 Discontinued
003 QUESTRAN LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1988/12/05 Discontinued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
提交状态日期提交类型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
2000/03/20 Supplemental 24 Approval Labeling STANDARD
1997/10/29 Supplemental 23 Approval Manufacturing (CMC) STANDARD
1997/08/22 Supplemental 22 Approval Labeling STANDARD
1995/09/22 Supplemental 18 Approval Labeling STANDARD
1995/09/22 Supplemental 17 Approval Labeling STANDARD
1994/12/12 Supplemental 19 Approval Labeling STANDARD
1993/01/07 Supplemental 16 Approval Manufacturing (CMC) STANDARD
1992/09/22 Supplemental 14 Approval Manufacturing (CMC) STANDARD
1992/08/11 Supplemental 15 Approval Labeling STANDARD
1991/09/10 Supplemental 12 Approval Labeling STANDARD
1991/03/12 Supplemental 9 Approval Manufacturing (CMC) STANDARD
1990/02/02 Supplemental 8 Approval Manufacturing (CMC) STANDARD
1989/11/27 Supplemental 7 Approval Labeling STANDARD
1989/02/21 Supplemental 3 Approval Manufacturing (CMC) STANDARD
1989/02/21 Supplemental 2 Approval Manufacturing (CMC) STANDARD
1989/02/21 Supplemental 1 Approval Manufacturing (CMC) STANDARD
1988/12/05 Original(原始申请) 1 Approval Type 3 - New Dosage Form 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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