药品注册申请号:018506
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 TRINALIN AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE TABLET, EXTENDED RELEASE;ORAL 1MG;120MG No No None 1982/03/23 1982/03/23 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
2002/12/12 SUPPL-25(补充) Approval Labeling STANDARD
2002/11/01 SUPPL-24(补充) Approval Labeling STANDARD
2000/11/01 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
2000/09/13 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
2000/08/04 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
2000/04/25 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1998/05/18 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1992/07/01 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1992/04/20 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1989/01/24 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1989/01/24 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1988/04/06 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1987/05/01 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1986/07/08 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1985/07/02 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1985/03/04 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1985/02/06 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1984/09/18 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1984/08/31 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1984/02/24 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1982/03/23 ORIG-1(原始申请) Approval Type 4 - New Combination 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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