药品注册申请号:050564
申请类型:NDA (新药申请)
申请人:US ANTIBIOTICS
申请人全名:US ANTIBIOTICS LLC
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 AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM TABLET;ORAL 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/08/06 1984/08/06 Discontinued
002 AUGMENTIN '500' AMOXICILLIN; CLAVULANATE POTASSIUM TABLET;ORAL 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/08/06 Discontinued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
2024/05/01 SUPPL-60(补充) Approval Labeling STANDARD
2022/08/25 SUPPL-59(补充) Approval Labeling STANDARD
2014/09/30 SUPPL-57(补充) Approval Manufacturing (CMC) PRIORITY
2013/01/22 SUPPL-55(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.
2013/01/22 SUPPL-53(补充) Approval Labeling STANDARD
2011/09/29 SUPPL-52(补充) Approval Labeling STANDARD
2008/12/04 SUPPL-50(补充) Approval Labeling STANDARD
2008/06/09 SUPPL-49(补充) Approval Labeling STANDARD
2008/03/26 SUPPL-51(补充) Approval Labeling STANDARD
2005/08/05 SUPPL-48(补充) Approval Labeling STANDARD
2004/08/30 SUPPL-47(补充) Approval Labeling STANDARD
2004/05/27 SUPPL-46(补充) Approval Labeling STANDARD
2003/07/25 SUPPL-43(补充) Approval Labeling STANDARD
2002/12/04 SUPPL-44(补充) Approval Manufacturing (CMC) PRIORITY
2002/10/17 SUPPL-45(补充) Approval Manufacturing (CMC) PRIORITY
2002/05/01 SUPPL-41(补充) Approval Manufacturing (CMC) PRIORITY
2002/04/10 SUPPL-34(补充) Approval Labeling STANDARD
2001/05/03 SUPPL-39(补充) Approval Manufacturing (CMC) PRIORITY
2001/04/17 SUPPL-40(补充) Approval Manufacturing (CMC) PRIORITY
1999/11/19 SUPPL-37(补充) Approval Manufacturing (CMC) PRIORITY
1999/09/23 SUPPL-36(补充) Approval Manufacturing (CMC) PRIORITY
1999/02/01 SUPPL-35(补充) Approval Manufacturing (CMC) PRIORITY
1998/02/12 SUPPL-33(补充) Approval Manufacturing (CMC) PRIORITY
1998/02/11 SUPPL-32(补充) Approval Labeling STANDARD
1997/03/19 SUPPL-31(补充) Approval Labeling STANDARD
1996/03/04 SUPPL-26(补充) Approval Labeling STANDARD
1996/02/16 SUPPL-22(补充) Approval Labeling STANDARD
1994/09/15 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
1994/07/06 SUPPL-25(补充) Approval Labeling STANDARD
1994/06/21 SUPPL-24(补充) Approval Manufacturing (CMC) PRIORITY
1992/09/16 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1992/07/21 SUPPL-21(补充) Approval Labeling
1992/06/22 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1992/05/21 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1991/12/14 SUPPL-16(补充) Approval Labeling
1991/11/22 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
1990/05/22 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
1989/03/09 SUPPL-12(补充) Approval Labeling
1989/02/07 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1988/11/29 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1988/05/05 SUPPL-9(补充) Approval Labeling
1988/02/10 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1987/11/27 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1987/10/29 SUPPL-6(补充) Approval Labeling
1986/11/21 SUPPL-1(补充) Approval Labeling
1985/12/21 SUPPL-4(补充) Approval Labeling
1985/11/25 SUPPL-3(补充) Approval Labeling
1984/08/06 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY
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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