药品注册申请号:201090
申请类型:ANDA (仿制药申请)
申请人:AUROBINDO PHARMA LTD
申请人全名:AUROBINDO PHARMA LTD
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 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 200MG/5ML;EQ 28.5MG BASE/5ML No No AB 2011/12/20 2011/12/20 Prescription
002 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 400MG/5ML;EQ 57MG BASE/5ML No No AB 2011/12/20 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-14(补充) Approval Labeling STANDARD
2024/04/25 SUPPL-11(补充) Approval Labeling STANDARD
2024/04/25 SUPPL-5(补充) Approval Labeling STANDARD
2015/02/09 SUPPL-2(补充) Approval Labeling STANDARD
2011/12/20 ORIG-1(原始申请) Approval Not Applicable
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:200MG/5ML;EQ 28.5MG 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
065066 001 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 200MG/5ML;EQ 28.5MG BASE/5ML Prescription No No AB 2002/06/05 SANDOZ
065098 001 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 200MG/5ML;EQ 28.5MG BASE/5ML Prescription No No AB 2002/12/16 SANDOZ INC
065089 001 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 200MG/5ML;EQ 28.5MG BASE/5ML Prescription No No AB 2004/05/25 TEVA
065191 002 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 200MG/5ML;EQ 28.5MG BASE/5ML Prescription No No AB 2005/01/25 HIKMA PHARMS
201090 001 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 200MG/5ML;EQ 28.5MG BASE/5ML Prescription No No AB 2011/12/20 AUROBINDO PHARMA LTD
205187 001 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 200MG/5ML;EQ 28.5MG BASE/5ML Prescription No No AB 2021/05/21 MICRO LABS LTD INDIA
活性成分:AMOXICILLIN; CLAVULANATE POTASSIUM 剂型/给药途径:FOR SUSPENSION;ORAL 规格:400MG/5ML;EQ 57MG 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
065066 002 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 400MG/5ML;EQ 57MG BASE/5ML Prescription No No AB 2002/06/05 SANDOZ
065098 002 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 400MG/5ML;EQ 57MG BASE/5ML Prescription No No AB 2002/12/16 SANDOZ INC
065089 002 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 400MG/5ML;EQ 57MG BASE/5ML Prescription No Yes AB 2004/05/25 TEVA
065191 001 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 400MG/5ML;EQ 57MG BASE/5ML Prescription No No AB 2005/01/25 HIKMA PHARMS
201090 002 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 400MG/5ML;EQ 57MG BASE/5ML Prescription No No AB 2011/12/20 AUROBINDO PHARMA LTD
205187 002 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 400MG/5ML;EQ 57MG BASE/5ML Prescription No No AB 2021/05/21 MICRO LABS LTD INDIA
210416 001 ANDA AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 400MG/5ML;EQ 57MG BASE/5ML Prescription No No AB 2023/12/11 DEVA HOLDING AS
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