药品注册申请号:016008
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 PERMITIL FLUPHENAZINE HYDROCHLORIDE CONCENTRATE;ORAL 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1965/04/07 Approved Prior to Jan 1, 1982 Discontinued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
2000/05/19 SUPPL-13(补充) Approval Labeling STANDARD
1999/07/26 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1989/07/28 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1989/04/13 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1989/04/13 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1988/10/04 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1987/02/26 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1986/09/11 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1982/04/19 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1965/04/07 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)
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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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