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
2008/01/22 SUPPL-52(补充) Approval Labeling STANDARD
2006/02/09 SUPPL-51(补充) Approval Labeling STANDARD
2000/12/19 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
2000/08/25 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL-46(补充) Approval Manufacturing (CMC) STANDARD
1993/03/18 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1993/01/21 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
1991/10/02 SUPPL-42(补充) Approval Manufacturing (CMC) STANDARD
1991/07/11 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1991/03/25 SUPPL-41(补充) Approval Labeling STANDARD
1989/12/18 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
1989/10/17 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
1989/05/30 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1989/05/30 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1988/04/29 SUPPL-12(补充) Approval Efficacy STANDARD
1987/12/02 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1986/07/31 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1986/07/31 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1985/12/11 SUPPL-28(补充) Approval Labeling STANDARD
1985/12/11 SUPPL-27(补充) Approval Labeling STANDARD
1985/12/11 SUPPL-26(补充) Approval Labeling STANDARD
1985/02/07 SUPPL-25(补充) Approval Labeling STANDARD
1985/01/18 SUPPL-21(补充) Approval Labeling STANDARD
1985/01/18 SUPPL-7(补充) Approval Labeling STANDARD
1985/01/15 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1985/01/15 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1984/10/05 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1984/05/03 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1983/06/16 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1983/05/25 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1983/04/06 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1983/01/31 SUPPL-18(补充) Approval Labeling STANDARD
1983/01/31 SUPPL-17(补充) Approval Labeling STANDARD
1982/07/27 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1982/07/12 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1981/12/21 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1981/06/12 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1981/04/01 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1979/10/30 ORIG-1(原始申请) 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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药品NDC数据与药品包装、标签说明书
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