药品注册申请号:050527
申请类型:NDA (新药申请)
申请人:WARNER CHILCOTT
申请人全名:WARNER CHILCOTT 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 DURICEF CEFADROXIL/CEFADROXIL HEMIHYDRATE FOR SUSPENSION;ORAL EQ 500MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1980/09/12 Approved Prior to Jan 1, 1982 Discontinued
002 DURICEF CEFADROXIL/CEFADROXIL HEMIHYDRATE FOR SUSPENSION;ORAL EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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 DURICEF CEFADROXIL/CEFADROXIL HEMIHYDRATE FOR SUSPENSION;ORAL EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
2007/06/05 SUPPL-22(补充) Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2003/12/16 SUPPL-21(补充) Approval Labeling STANDARD
2002/05/03 SUPPL-20(补充) Approval Labeling STANDARD
1999/03/26 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1996/10/15 SUPPL-17(补充) Approval Labeling STANDARD
1995/12/05 SUPPL-16(补充) Approval Labeling STANDARD
1991/08/30 SUPPL-9(补充) Approval Efficacy
1989/05/03 SUPPL-11(补充) Approval Labeling
1988/09/12 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1987/03/05 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1982/05/21 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1982/01/20 SUPPL-12(补充) Approval Labeling
1981/10/27 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1981/08/07 SUPPL-5(补充) Approval Labeling
1981/06/30 SUPPL-4(补充) Approval Labeling
1981/03/31 SUPPL-3(补充) Approval Labeling
1980/12/08 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1980/11/04 SUPPL-1(补充) Approval Labeling
1980/09/12 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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