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 |
2021/05/17 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
2018/08/27 |
ORIG-1(原始申请) |
Approval |
|
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 | RLD | RS | TE 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
|
ATLAS PHARMS LLC |
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 |
Prescription |
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 |
Prescription |
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 |
Prescription |
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 | RLD | RS | TE 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
|
ATLAS PHARMS LLC |
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 |
Prescription |
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 |
Prescription |
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 |
Prescription |
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 | RLD | RS | TE 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
|
ATLAS PHARMS LLC |
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 |
Prescription |
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 |
Prescription |
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 |
Prescription |
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 |