药品注册申请号:050575
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 '125' AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 125MG/5ML;EQ 31.25MG BASE/5ML Yes No AB 1984/08/06 1984/08/06 Prescription
002 AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 250MG/5ML;EQ 62.5MG BASE/5ML Yes Yes AB 1984/08/06 Prescription
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
2022/08/25 SUPPL-48(补充) Approval Labeling STANDARD
2014/09/30 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
2013/01/22 SUPPL-42(补充) Approval Labeling UNKNOWN Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2013/01/22 SUPPL-40(补充) Approval Labeling STANDARD
2011/09/29 SUPPL-39(补充) Approval Labeling STANDARD
2008/12/04 SUPPL-37(补充) Approval Labeling STANDARD
2008/03/27 SUPPL-38(补充) Approval Labeling STANDARD
2004/08/11 SUPPL-36(补充) Approval Labeling STANDARD
2004/06/03 SUPPL-35(补充) Approval Labeling STANDARD
2003/05/12 SUPPL-32(补充) Approval Labeling STANDARD
2002/12/04 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
2002/10/17 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
2002/04/10 SUPPL-25(补充) Approval Labeling STANDARD
2001/04/17 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1999/11/19 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1999/09/23 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1999/02/01 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1998/02/11 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1998/02/11 SUPPL-23(补充) Approval Labeling STANDARD
1997/03/19 SUPPL-22(补充) Approval Labeling STANDARD
1996/03/04 SUPPL-19(补充) Approval Labeling STANDARD
1996/02/16 SUPPL-16(补充) Approval Labeling STANDARD
1994/09/15 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1994/07/06 SUPPL-18(补充) Approval Labeling STANDARD
1994/04/18 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1992/07/21 SUPPL-15(补充) Approval Labeling
1991/12/05 SUPPL-12(补充) Approval Labeling
1991/11/05 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1991/05/22 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1984/08/06 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)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
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
活性成分:AMOXICILLIN; CLAVULANATE POTASSIUM 剂型/给药途径:FOR SUSPENSION;ORAL 规格:125MG/5ML;EQ 31.25MG BASE/5ML 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
050575 001 NDA AUGMENTIN '125' AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 125MG/5ML;EQ 31.25MG BASE/5ML Prescription Yes No AB 1984/08/06 US ANTIBIOTICS
209371 001 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 125MG/5ML;EQ 31.25MG BASE/5ML Prescription No No AB 2019/04/19 AUROBINDO PHARMA
活性成分:AMOXICILLIN; CLAVULANATE POTASSIUM 剂型/给药途径:FOR SUSPENSION;ORAL 规格:250MG/5ML;EQ 62.5MG BASE/5ML 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
050575 002 NDA AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 250MG/5ML;EQ 62.5MG BASE/5ML Prescription Yes Yes AB 1984/08/06 US ANTIBIOTICS
065431 001 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 250MG/5ML;EQ 62.5MG BASE/5ML Prescription No No AB 2008/11/25 WOCKHARDT BIO AG
209371 002 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 250MG/5ML;EQ 62.5MG BASE/5ML Prescription No No AB 2019/04/19 AUROBINDO PHARMA
210374 001 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 250MG/5ML;EQ 62.5MG BASE/5ML Prescription No No AB 2023/11/29 DEVA HOLDING AS
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