药品注册申请号:010775
申请类型:NDA (新药申请)
申请人:SCHERING
申请人全名:SCHERING CORP SUB SCHERING PLOUGH CORP
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001 TRILAFON PERPHENAZINE TABLET;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1957/02/27 Approved Prior to Jan 1, 1982 Discontinued
002 TRILAFON PERPHENAZINE TABLET;ORAL 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 TRILAFON PERPHENAZINE TABLET;ORAL 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 TRILAFON PERPHENAZINE TABLET;ORAL 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
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
2002/05/10 SUPPL-31(补充) Approval Labeling STANDARD
2001/10/18 SUPPL-30(补充) Approval Labeling STANDARD
2001/03/15 SUPPL-29(补充) Approval Labeling STANDARD
2000/06/01 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
2000/03/03 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1999/04/07 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1998/08/21 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1995/10/20 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1982/03/29 SUPPL-15(补充) Approval Labeling STANDARD
1957/02/27 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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