药品注册申请号：062226
申请类型：ANDA (仿制药申请)
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 125MG/5ML No No AB 1979/11/27 Approved Prior to Jan 1, 1982 Prescription
002 AMOXIL AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML No No AB Approved Prior to Jan 1, 1982 Prescription
003 LAROTID AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML No No AB Approved Prior to Jan 1, 1982 Prescription
004 LAROTID AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML No No AB Approved Prior to Jan 1, 1982 Prescription
005 AMOXIL AMOXICILLIN FOR SUSPENSION;ORAL 50MG/ML No No AB Approved Prior to Jan 1, 1982 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-40（补充） Approval Labeling STANDARD
2017/05/18 SUPPL-39（补充） Approval Labeling STANDARD
2014/12/05 SUPPL-35（补充） Approval Labeling
2014/11/17 SUPPL-37（补充） Approval Labeling
2009/03/12 SUPPL-34（补充） Approval Labeling
2009/03/06 SUPPL-33（补充） Approval Labeling
2009/02/17 SUPPL-32（补充） Approval Labeling
2005/09/01 SUPPL-31（补充） Approval Labeling
2004/10/07 SUPPL-30（补充） Approval Labeling
2002/12/09 SUPPL-29（补充） Approval Manufacturing (CMC)
2001/08/22 SUPPL-27（补充） Approval Labeling
2001/05/31 SUPPL-26（补充） Approval Manufacturing (CMC)
1999/06/08 SUPPL-23（补充） Approval Labeling
1998/08/04 SUPPL-20（补充） Approval Labeling
1998/08/04 SUPPL-15（补充） Approval Labeling
1998/04/20 SUPPL-22（补充） Approval Manufacturing (CMC)
1997/09/24 SUPPL-21（补充） Approval Labeling
1995/05/22 SUPPL-18（补充） Approval Labeling
1993/04/19 SUPPL-17（补充） Approval Labeling
1993/03/09 SUPPL-14（补充） Approval Manufacturing (CMC)
1992/06/23 SUPPL-13（补充） Approval Manufacturing (CMC)
1992/02/11 SUPPL-16（补充） Approval Labeling
1989/07/24 SUPPL-12（补充） Approval Manufacturing (CMC)
1979/11/27 ORIG-1（原始申请） Approval
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
无
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
无
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:125MG/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
062226 001 ANDA AMOXIL AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Prescription No No AB Approved Prior to Jan 1, 1982 US ANTIBIOTICS
062226 003 ANDA LAROTID AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Prescription No No AB Approved Prior to Jan 1, 1982 US ANTIBIOTICS
062927 001 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Discontinued No No AB 1988/11/25 ENDO OPERATIONS
065322 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Prescription No No AB 2006/06/19 HIKMA
065387 001 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Prescription No No AB 2007/03/26 SANDOZ
204030 001 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Prescription No No AB 2014/09/15 AUROBINDO PHARMA LTD
活性成分:AMOXICILLIN 剂型/给药途径:FOR SUSPENSION;ORAL 规格:250MG/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
061931 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No Yes AB Approved Prior to Jan 1, 1982 TEVA
062226 002 ANDA AMOXIL AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No No AB Approved Prior to Jan 1, 1982 US ANTIBIOTICS
062226 004 ANDA LAROTID AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No No AB Approved Prior to Jan 1, 1982 US ANTIBIOTICS
062927 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Discontinued No No AB 1988/11/25 ENDO OPERATIONS
065322 001 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No No AB 2006/06/19 HIKMA
065387 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No No AB 2007/03/26 SANDOZ
204030 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No No AB 2014/09/15 AUROBINDO PHARMA LTD
活性成分:AMOXICILLIN 剂型/给药途径:FOR SUSPENSION;ORAL 规格:125MG/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
062226 001 ANDA AMOXIL AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Prescription No No AB Approved Prior to Jan 1, 1982 US ANTIBIOTICS
062226 003 ANDA LAROTID AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Prescription No No AB Approved Prior to Jan 1, 1982 US ANTIBIOTICS
062927 001 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Discontinued No No AB 1988/11/25 ENDO OPERATIONS
065322 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Prescription No No AB 2006/06/19 HIKMA
065387 001 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Prescription No No AB 2007/03/26 SANDOZ
204030 001 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 125MG/5ML Prescription No No AB 2014/09/15 AUROBINDO PHARMA LTD
活性成分:AMOXICILLIN 剂型/给药途径:FOR SUSPENSION;ORAL 规格:250MG/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
061931 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No Yes AB Approved Prior to Jan 1, 1982 TEVA
062226 002 ANDA AMOXIL AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No No AB Approved Prior to Jan 1, 1982 US ANTIBIOTICS
062226 004 ANDA LAROTID AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No No AB Approved Prior to Jan 1, 1982 US ANTIBIOTICS
062927 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Discontinued No No AB 1988/11/25 ENDO OPERATIONS
065322 001 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No No AB 2006/06/19 HIKMA
065387 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No No AB 2007/03/26 SANDOZ
204030 002 ANDA AMOXICILLIN AMOXICILLIN FOR SUSPENSION;ORAL 250MG/5ML Prescription No No AB 2014/09/15 AUROBINDO PHARMA LTD
活性成分:AMOXICILLIN 剂型/给药途径:FOR SUSPENSION;ORAL 规格:50MG/ML 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
062226 005 ANDA AMOXIL AMOXICILLIN FOR SUSPENSION;ORAL 50MG/ML Prescription No No AB Approved Prior to Jan 1, 1982 US ANTIBIOTICS
061931 003 ANDA AMOXICILLIN PEDIATRIC AMOXICILLIN FOR SUSPENSION;ORAL 50MG/ML Prescription No No AB 1982/12/01 TEVA
更多信息
药品NDC数据与药品包装、标签说明书
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