药品注册申请号：077880
申请类型：ANDA (仿制药申请)
申请人：AMNEAL PHARMS NY
申请人全名：AMNEAL PHARMACEUTICALS NY 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 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG No No AB 2006/06/05 2006/06/05 Discontinued
002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG No No AB 2006/06/05 Discontinued
003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM No No AB 2006/06/05 Discontinued
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
2006/06/05 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
2019/08/27 SUPPL-22（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert,Labeling-Container/Carton Labels STANDARD
2019/08/27 SUPPL-21（补充） Approval Labeling-Package Insert STANDARD
2008/03/20 SUPPL-2（补充） Approval Manufacturing (CMC)-Facility
2007/02/15 SUPPL-1（补充） Approval Labeling
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;ORAL; 规格:500MG; 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
075972 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2002/01/24 CHARTWELL
076033 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2002/01/24 ANDA REPOSITORY
075973 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2002/01/25 MYLAN
075965 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2002/01/25 EPIC PHARMA LLC
075967 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Discontinued No No AB 2002/01/29 SUN PHARM INDS INC
075984 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Discontinued No No AB 2002/04/23 APOTEX
077095 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2005/01/14 AUROBINDO
077064 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2005/04/18 ZYDUS PHARMS USA
077880 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Discontinued No No AB 2006/06/05 AMNEAL PHARMS NY
077787 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2006/08/23 DR REDDYS LABS INC
078170 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Discontinued No No AB 2008/05/23 GLENMARK PHARMS LTD
090564 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2010/04/22 GRANULES INDIA
091184 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2010/11/01 ALKEM
090666 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Discontinued No No AB 2011/12/07 APOTEX
090888 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2012/03/12 MARKSANS PHARMA
203769 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2013/09/11 SCIEGEN PHARMS INC
203686 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2014/08/28 ZYDUS HLTHCARE
205096 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2016/07/11 CSPC OUYI
209882 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2018/08/27 LAURUS
213320 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG Prescription No No AB 2021/12/03 HARMAN FINOCHEM
>>>活性成分:METFORMIN HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:850MG; 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
075972 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2002/01/24 CHARTWELL
076033 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2002/01/24 ANDA REPOSITORY
075973 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2002/01/25 MYLAN
075965 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2002/01/25 EPIC PHARMA LLC
075967 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Discontinued No No AB 2002/01/29 SUN PHARM INDS INC
075984 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Discontinued No No AB 2002/04/23 APOTEX
077095 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2005/01/14 AUROBINDO
077064 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2005/04/18 ZYDUS PHARMS USA
077880 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Discontinued No No AB 2006/06/05 AMNEAL PHARMS NY
077787 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2006/08/23 DR REDDYS LABS INC
078170 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Discontinued No No AB 2008/05/23 GLENMARK PHARMS LTD
090564 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2010/04/22 GRANULES INDIA
091184 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2010/11/01 ALKEM
090666 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Discontinued No No AB 2011/12/07 APOTEX
090888 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2012/03/12 MARKSANS PHARMA
203769 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2013/09/11 SCIEGEN PHARMS INC
203686 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2014/08/28 ZYDUS HLTHCARE
205096 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2016/07/11 CSPC OUYI
209882 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2018/08/27 LAURUS
213320 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG Prescription No No AB 2021/12/03 HARMAN FINOCHEM
>>>活性成分:METFORMIN HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:1GM; 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
075972 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2002/01/24 CHARTWELL
076033 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2002/01/24 ANDA REPOSITORY
075973 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2002/01/25 MYLAN
075965 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2002/01/25 EPIC PHARMA LLC
075967 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Discontinued No No AB 2002/01/29 SUN PHARM INDS INC
075984 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Discontinued No No AB 2002/04/23 APOTEX
077095 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2005/01/14 AUROBINDO
077064 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2005/04/18 ZYDUS PHARMS USA
077880 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Discontinued No No AB 2006/06/05 AMNEAL PHARMS NY
077787 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2006/08/23 DR REDDYS LABS INC
078170 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Discontinued No No AB 2008/05/23 GLENMARK PHARMS LTD
090564 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No Yes AB 2010/04/22 GRANULES INDIA
091184 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2010/11/01 ALKEM
090666 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Discontinued No No AB 2011/12/07 APOTEX
090888 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2012/03/12 MARKSANS PHARMA
203769 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2013/09/11 SCIEGEN PHARMS INC
203686 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2014/08/28 ZYDUS HLTHCARE
205096 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2016/07/11 CSPC OUYI
209882 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2018/08/27 LAURUS
213320 003 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM Prescription No No AB 2021/12/03 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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