药品注册申请号:018191
申请类型:NDA (新药申请)
申请人:SCHERING PLOUGH
申请人全名:SCHERING PLOUGH HEALTHCARE PRODUCTS 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 AFRINOL PSEUDOEPHEDRINE SULFATE TABLET, EXTENDED RELEASE;ORAL 120MG Yes No None 1980/10/30 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
2001/07/11 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
2001/01/24 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
2000/12/01 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
2000/10/17 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
2000/04/18 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1998/11/17 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1998/10/07 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1998/09/22 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1996/03/15 SUPPL-8(补充) Approval Labeling STANDARD
1989/01/24 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1987/09/02 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1986/07/08 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1984/09/18 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1983/01/21 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1981/04/10 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1980/10/30 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer 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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