药品注册申请号:020156
申请类型:NDA (新药申请)
申请人:BRISTOL
申请人全名:BRISTOL MYERS SQUIBB 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 VIDEX DIDANOSINE FOR SOLUTION;ORAL 10MG/ML Yes No None 1991/10/09 1991/10/09 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
2018/12/17 SUPPL-54(补充) Approval Labeling STANDARD
2018/01/25 SUPPL-53(补充) Approval Labeling STANDARD
2014/08/08 SUPPL-51(补充) Approval Labeling STANDARD
2011/11/18 SUPPL-48(补充) Approval Labeling 901 REQUIRED
2011/05/10 SUPPL-47(补充) Approval REMS N/A
2010/01/25 SUPPL-46(补充) Approval REMS UNKNOWN
2009/06/11 SUPPL-44(补充) Approval Labeling STANDARD
2006/11/29 SUPPL-40(补充) Approval Labeling STANDARD
2006/08/18 SUPPL-39(补充) Approval Labeling STANDARD
2004/01/21 SUPPL-35(补充) Approval Labeling STANDARD
2003/03/04 SUPPL-33(补充) Approval Labeling STANDARD
2002/09/25 SUPPL-32(补充) Approval Labeling STANDARD
2002/09/25 SUPPL-31(补充) Approval Labeling STANDARD
2002/04/01 SUPPL-29(补充) Approval Efficacy UNKNOWN
2001/11/16 SUPPL-28(补充) Approval Labeling STANDARD
2001/09/10 SUPPL-27(补充) Approval Labeling STANDARD
2001/07/27 SUPPL-26(补充) Approval Labeling STANDARD
2000/07/24 SUPPL-25(补充) Approval Efficacy STANDARD
2000/07/24 SUPPL-24(补充) Approval Labeling STANDARD
2000/07/03 SUPPL-23(补充) Approval Labeling STANDARD
1999/10/28 SUPPL-22(补充) Approval Efficacy PRIORITY
1999/07/01 SUPPL-21(补充) Approval Efficacy STANDARD
1998/06/23 SUPPL-19(补充) Approval Manufacturing (CMC)
1998/04/23 SUPPL-18(补充) Approval Labeling STANDARD
1998/03/05 SUPPL-20(补充) Approval Manufacturing (CMC)
1996/07/17 SUPPL-16(补充) Approval Efficacy STANDARD
1996/06/26 SUPPL-17(补充) Approval Labeling STANDARD
1996/06/26 SUPPL-12(补充) Approval Labeling STANDARD
1996/03/13 SUPPL-15(补充) Approval Manufacturing (CMC)
1995/08/21 SUPPL-11(补充) Approval Labeling STANDARD
1995/08/21 SUPPL-10(补充) Approval Labeling STANDARD
1995/08/21 SUPPL-8(补充) Approval Labeling STANDARD
1995/08/21 SUPPL-6(补充) Approval Labeling STANDARD
1995/07/14 SUPPL-14(补充) Approval Manufacturing (CMC)
1995/06/15 SUPPL-13(补充) Approval Labeling STANDARD
1994/08/05 SUPPL-7(补充) Approval Efficacy PRIORITY
1994/02/10 SUPPL-9(补充) Approval Labeling STANDARD
1994/02/10 SUPPL-5(补充) Approval Labeling STANDARD
1992/09/25 SUPPL-4(补充) Approval Efficacy
1991/10/09 ORIG-1(原始申请) Approval Type 3 - New Dosage Form PRIORITY
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
001 4861759 2006/08/29 U-248 PDF格式**本条是由Drugfuture回溯的历史信息**
4861759*PED 2007/03/01 U-248 PDF格式**本条是由Drugfuture回溯的历史信息**
5254539 2006/08/29 U-248 PDF格式**本条是由Drugfuture回溯的历史信息**
5254539*PED 2007/03/01 U-248 PDF格式**本条是由Drugfuture回溯的历史信息**
5616566 2006/08/29 U-180 PDF格式**本条是由Drugfuture回溯的历史信息**
5616566*PED 2007/03/01 U-180 PDF格式**本条是由Drugfuture回溯的历史信息**
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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