药品注册申请号:050760
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 AMOXIL AMOXICILLIN FOR SUSPENSION;ORAL 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1999/04/15 1999/04/15 Discontinued
002 AMOXIL AMOXICILLIN FOR SUSPENSION;ORAL 400MG/5ML Yes No AB 1999/04/15 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
2024/05/01 SUPPL-23(补充) Approval Labeling STANDARD
2022/11/02 SUPPL-21(补充) Approval Labeling STANDARD
2015/12/03 SUPPL-20(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.
2015/09/24 SUPPL-19(补充) Approval Labeling STANDARD
2014/07/30 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
2014/05/29 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
2011/11/16 SUPPL-15(补充) Approval Labeling UNKNOWN
2011/11/16 SUPPL-13(补充) Approval Labeling STANDARD
2011/11/16 SUPPL-12(补充) Approval Labeling STANDARD
2008/06/09 SUPPL-10(补充) Approval Labeling STANDARD
2008/03/28 SUPPL-11(补充) Approval Labeling STANDARD
2006/01/26 SUPPL-9(补充) Approval Labeling STANDARD
2004/07/13 SUPPL-8(补充) Approval Labeling STANDARD
2003/12/18 SUPPL-7(补充) Approval Labeling STANDARD
2003/05/12 SUPPL-3(补充) Approval Labeling STANDARD
2002/12/04 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
2002/05/01 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
2002/04/25 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
2001/04/17 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
2000/05/16 SUPPL-1(补充) Approval Labeling STANDARD
1999/04/15 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 剂型/给药途径:FOR SUSPENSION;ORAL 规格:400MG/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
050760 002 NDA AMOXIL AMOXICILLIN FOR SUSPENSION;ORAL 400MG/5ML Prescription Yes No AB 1999/04/15 US ANTIBIOTICS
065119 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 400MG/5ML Prescription No Yes AB 2002/12/04 TEVA
065325 001 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 400MG/5ML Prescription No No AB 2006/06/19 HIKMA
065334 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 400MG/5ML Prescription No No AB 2006/12/28 AUROBINDO
065378 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 400MG/5ML Prescription No No AB 2007/03/26 SANDOZ
065319 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 400MG/5ML Prescription No No AB 2007/06/18 CHARTWELL RX
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