药品注册申请号:018084
申请类型:NDA (新药申请)
申请人:ORTHO MCNEIL JANSSEN
申请人全名:ORTHO MCNEIL JANSSEN PHARMACEUTICALS 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 TOLECTIN DS TOLMETIN SODIUM CAPSULE;ORAL EQ 400MG BASE Yes No None 1979/10/30 Approved Prior to Jan 1, 1982 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
2008/01/22 SUPPL 52 Approval Labeling STANDARD
2006/02/09 SUPPL 51 Approval Labeling STANDARD
2000/12/19 SUPPL 49 Approval Manufacturing (CMC) STANDARD
2000/08/25 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1993/03/18 SUPPL 44 Approval Manufacturing (CMC) STANDARD
1993/01/21 SUPPL 43 Approval Manufacturing (CMC) STANDARD
1991/10/02 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1991/07/11 SUPPL 40 Approval Manufacturing (CMC) STANDARD
1991/03/25 SUPPL 41 Approval Labeling STANDARD
1989/12/18 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1989/10/17 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1989/05/30 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1989/05/30 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1988/04/29 SUPPL 12 Approval Efficacy STANDARD
1987/12/02 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1986/07/31 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1986/07/31 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1985/12/11 SUPPL 28 Approval Labeling STANDARD
1985/12/11 SUPPL 27 Approval Labeling STANDARD
1985/12/11 SUPPL 26 Approval Labeling STANDARD
1985/02/07 SUPPL 25 Approval Labeling STANDARD
1985/01/18 SUPPL 21 Approval Labeling STANDARD
1985/01/18 SUPPL 7 Approval Labeling STANDARD
1985/01/15 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1985/01/15 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1984/10/05 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1984/05/03 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1983/06/16 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1983/05/25 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1983/04/06 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1983/01/31 SUPPL 18 Approval Labeling STANDARD
1983/01/31 SUPPL 17 Approval Labeling STANDARD
1982/07/27 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1982/07/12 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1981/12/21 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1981/06/12 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1981/04/01 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1979/10/30 ORIG 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)
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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