药品注册申请号:018731
申请类型:NDA (新药申请)
申请人:BRISTOL MYERS SQUIBB
申请人全名:BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
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 BUSPAR BUSPIRONE HYDROCHLORIDE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1986/09/29 1986/09/29 Discontinued
002 BUSPAR BUSPIRONE HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1986/09/29 Discontinued
003 BUSPAR BUSPIRONE HYDROCHLORIDE TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1996/04/22 Discontinued
004 BUSPAR BUSPIRONE HYDROCHLORIDE TABLET;ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1996/04/22 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2010/11/22 SUPPL 51 Approval Labeling PRIORITY
2007/09/21 SUPPL 48 Approval Labeling PRIORITY
2002/02/07 SUPPL 46 Approval Labeling PRIORITY
2001/07/19 SUPPL 43 Approval Efficacy PRIORITY
2001/05/03 SUPPL 45 Approval Labeling PRIORITY
2001/05/03 SUPPL 39 Approval Labeling PRIORITY
2000/04/25 SUPPL 42 Approval Manufacturing (CMC) PRIORITY
1999/11/01 SUPPL 41 Approval Manufacturing (CMC) PRIORITY
1999/07/27 SUPPL 40 Approval Manufacturing (CMC) PRIORITY
1999/01/27 SUPPL 38 Approval Manufacturing (CMC) PRIORITY
1998/06/19 SUPPL 36 Approval Manufacturing (CMC) PRIORITY
1998/05/20 SUPPL 34 Approval Labeling PRIORITY
1998/05/20 SUPPL 33 Approval Labeling PRIORITY
1998/04/03 SUPPL 35 Approval Manufacturing (CMC) PRIORITY
1998/03/02 SUPPL 20 Approval Labeling PRIORITY
1996/12/30 SUPPL 32 Approval Manufacturing (CMC) PRIORITY
1996/06/19 SUPPL 30 Approval Manufacturing (CMC) PRIORITY
1996/04/22 SUPPL 31 Approval Efficacy PRIORITY
1996/04/22 SUPPL 27 Approval Labeling PRIORITY
1996/04/22 SUPPL 25 Approval Manufacturing (CMC) PRIORITY
1996/03/20 SUPPL 29 Approval Manufacturing (CMC) PRIORITY
1993/09/23 SUPPL 26 Approval Labeling PRIORITY
1991/07/31 SUPPL 18 Approval Labeling PRIORITY
1990/10/05 SUPPL 23 Approval Manufacturing (CMC) PRIORITY
1990/01/26 SUPPL 21 Approval Manufacturing (CMC) PRIORITY
1990/01/26 SUPPL 19 Approval Manufacturing (CMC) PRIORITY
1989/07/25 SUPPL 8 Approval Labeling PRIORITY
1989/07/25 SUPPL 6 Approval Manufacturing (CMC) PRIORITY
1989/04/28 SUPPL 17 Approval Manufacturing (CMC) PRIORITY
1989/03/02 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
1989/03/02 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
1988/11/02 SUPPL 11 Approval Labeling PRIORITY
1988/10/13 SUPPL 16 Approval Manufacturing (CMC) PRIORITY
1988/06/23 SUPPL 10 Approval Manufacturing (CMC) PRIORITY
1987/08/10 SUPPL 9 Approval Labeling PRIORITY
1987/04/23 SUPPL 5 Approval Manufacturing (CMC) PRIORITY
1986/12/16 SUPPL 4 Approval Manufacturing (CMC) PRIORITY
1986/12/16 SUPPL 3 Approval Manufacturing (CMC) PRIORITY
1986/09/29 ORIG 1 Approval Type 1 - New Molecular Entity 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
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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