药品注册申请号:016792
申请类型:NDA (新药申请)
申请人:ODYSSEY PHARMS
申请人全名:ODYSSEY 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 SURMONTIL TRIMIPRAMINE MALEATE CAPSULE;ORAL EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1979/06/12 Approved Prior to Jan 1, 1982 Discontinued
002 SURMONTIL TRIMIPRAMINE MALEATE CAPSULE;ORAL EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 SURMONTIL TRIMIPRAMINE MALEATE CAPSULE;ORAL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/09/15 Discontinued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
2014/09/30 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
2014/07/17 SUPPL-37(补充) Approval Labeling 901 REQUIRED
2013/12/23 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
2012/12/03 SUPPL-34(补充) Approval Labeling STANDARD
2007/08/01 SUPPL-25(补充) Approval Labeling STANDARD
2005/01/12 SUPPL-24(补充) Approval Labeling STANDARD
2000/05/01 SUPPL-20(补充) Approval Labeling STANDARD
2000/04/27 SUPPL-19(补充) Approval Labeling STANDARD
2000/04/27 SUPPL-18(补充) Approval Labeling STANDARD
2000/04/27 SUPPL-15(补充) Approval Labeling
1992/04/03 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1992/04/03 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1991/12/16 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1988/06/17 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1988/04/20 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1987/07/24 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1987/02/02 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1982/11/12 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1982/10/05 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1982/09/15 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1981/08/24 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1981/03/26 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1980/07/08 SUPPL-1(补充) Approval Labeling
1979/06/12 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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
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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