药品注册申请号：079118
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 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG No No AB1 2012/07/20 2012/07/20 Prescription
002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG No No AB 2012/07/20 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2012/07/20 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/04/15 SUPPL-16（补充） Approval Labeling-Package Insert UNKNOWN
2019/01/02 SUPPL-9（补充） Approval Labeling-Package Insert STANDARD
2019/01/02 SUPPL-8（补充） Approval Labeling-Package Insert 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
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:METFORMIN HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:500MG; 治疗等效代码:AB1<<<
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
076269 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2004/06/18 TEVA
076873 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2004/12/14 SANDOZ
077060 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2005/04/20 ZYDUS LIFESCIENCES
077336 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Discontinued No No AB1 2006/02/09 SUN PHARM INDS (IN)
076756 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2006/07/26 NOSTRUM PHARMS LLC
078596 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2008/01/03 AMNEAL PHARMS NY
078321 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2008/04/17 CSPC OUYI
201991 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2012/01/18 INVENTIA
079118 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2012/07/20 AUROBINDO PHARMA LTD
090295 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2016/04/29 MARKSANS PHARMA
206955 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2016/12/07 MACLEODS PHARMS LTD
207427 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2016/12/13 REGCON HOLDINGS
202306 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2017/02/23 MEDICAP LABS
209313 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2018/03/16 GRANULES
209303 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2018/03/19 ALIGNSCIENCE PHARMA
208880 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2018/09/10 PRINSTON INC
211052 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2018/09/24 YICHANG HUMANWELL
206145 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2018/10/22 ALKEM LABS LTD
213359 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2021/08/11 UNICHEM
217631 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2023/10/05 LAURUS
218673 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB1 2024/07/05 HARMAN FINOCHEM
>>>活性成分:METFORMIN HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:750MG; 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
076864 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2005/04/12 TEVA
076869 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2005/04/12 ACTAVIS LABS FL INC
077078 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2005/04/21 ZYDUS LIFESCIENCES
077336 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Discontinued No No AB 2006/02/09 SUN PHARM INDS (IN)
078596 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2008/01/03 AMNEAL PHARMS NY
078321 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2008/04/17 CSPC OUYI
076756 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2011/12/12 NOSTRUM PHARMS LLC
079118 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2012/07/20 AUROBINDO PHARMA LTD
090295 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2016/04/29 MARKSANS PHARMA
206955 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2016/12/07 MACLEODS PHARMS LTD
207427 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2016/12/13 REGCON HOLDINGS
202306 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2017/02/23 MEDICAP LABS
209313 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2018/03/16 GRANULES
208880 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2018/09/10 PRINSTON INC
211052 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2018/09/24 YICHANG HUMANWELL
206145 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No Yes AB 2018/10/22 ALKEM LABS LTD
213359 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2021/08/11 UNICHEM
217631 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2023/10/05 LAURUS
218673 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 750MG Prescription No No AB 2024/07/05 HARMAN FINOCHEM
更多信息
药品NDC数据与药品包装、标签说明书
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