药品注册申请号:016640
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 CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1973/08/03 Approved Prior to Jan 1, 1982 Discontinued
003 QUESTRAN CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
1997/08/22 Supplemental 74 Approval Labeling STANDARD
1995/09/22 Supplemental 69 Approval Labeling STANDARD
1995/09/22 Supplemental 68 Approval Labeling STANDARD
1994/12/12 Supplemental 71 Approval Labeling STANDARD
1994/12/12 Supplemental 70 Approval Labeling STANDARD
1994/12/07 Supplemental 33 Approval Labeling STANDARD
1993/01/07 Supplemental 67 Approval Manufacturing (CMC) STANDARD
1992/09/22 Supplemental 65 Approval Manufacturing (CMC) STANDARD
1992/08/11 Supplemental 66 Approval Labeling STANDARD
1991/10/24 Supplemental 60 Approval Labeling STANDARD
1991/09/10 Supplemental 63 Approval Labeling STANDARD
1991/03/06 Supplemental 57 Approval Manufacturing (CMC) STANDARD
1990/05/25 Supplemental 59 Approval Manufacturing (CMC) STANDARD
1990/03/05 Supplemental 58 Approval Manufacturing (CMC) STANDARD
1990/02/02 Supplemental 56 Approval Manufacturing (CMC) STANDARD
1990/01/22 Supplemental 54 Approval Manufacturing (CMC) STANDARD
1989/11/28 Supplemental 55 Approval Labeling STANDARD
1989/03/02 Supplemental 42 Approval Manufacturing (CMC) STANDARD
1989/02/23 Supplemental 50 Approval Manufacturing (CMC) STANDARD
1988/12/01 Supplemental 49 Approval Manufacturing (CMC) STANDARD
1988/10/11 Supplemental 48 Approval Manufacturing (CMC) STANDARD
1988/08/26 Supplemental 47 Approval Manufacturing (CMC) STANDARD
1988/08/26 Supplemental 46 Approval Manufacturing (CMC) STANDARD
1988/07/14 Supplemental 45 Approval Manufacturing (CMC) STANDARD
1988/07/14 Supplemental 44 Approval Manufacturing (CMC) STANDARD
1988/07/14 Supplemental 43 Approval Manufacturing (CMC) STANDARD
1988/06/29 Supplemental 40 Approval Manufacturing (CMC) STANDARD
1988/03/25 Supplemental 39 Approval Manufacturing (CMC) STANDARD
1988/03/18 Supplemental 38 Approval Manufacturing (CMC) STANDARD
1988/02/16 Supplemental 36 Approval Manufacturing (CMC) STANDARD
1988/01/05 Supplemental 37 Approval Manufacturing (CMC) STANDARD
1987/11/19 Supplemental 35 Approval Manufacturing (CMC) STANDARD
1987/11/19 Supplemental 34 Approval Manufacturing (CMC) STANDARD
1987/09/18 Supplemental 30 Approval Manufacturing (CMC) STANDARD
1986/09/19 Supplemental 26 Approval Manufacturing (CMC) STANDARD
1986/03/12 Supplemental 25 Approval Manufacturing (CMC) STANDARD
1986/02/25 Supplemental 27 Approval Labeling STANDARD
1986/01/24 Supplemental 28 Approval Manufacturing (CMC) STANDARD
1985/11/26 Supplemental 23 Approval Manufacturing (CMC) STANDARD
1985/11/01 Supplemental 22 Approval Manufacturing (CMC) STANDARD
1985/09/12 Supplemental 24 Approval Manufacturing (CMC) STANDARD
1984/12/21 Supplemental 21 Approval Labeling STANDARD
1984/06/14 Supplemental 16 Approval Manufacturing (CMC) STANDARD
1984/05/11 Supplemental 17 Approval Labeling STANDARD
1983/11/30 Supplemental 14 Approval Labeling STANDARD
1983/06/24 Supplemental 13 Approval Labeling STANDARD
1982/08/16 Supplemental 12 Approval Manufacturing (CMC) STANDARD
1982/07/26 Supplemental 11 Approval Manufacturing (CMC) STANDARD
1982/06/16 Supplemental 10 Approval Manufacturing (CMC) STANDARD
1981/07/08 Supplemental 9 Approval Labeling STANDARD
1977/02/17 Supplemental 5 Approval Labeling STANDARD
1973/08/03 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
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与本品治疗等效的药品
本品无治疗等效药品
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