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 |
2024/01/05 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/10/05 |
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, 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 | RLD | RS | TE 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 |
Prescription |
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
|
BEXIMCO PHARMS USA |
202306 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB1 |
2017/02/23
|
INTELLIPHARMACEUTICS |
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 | RLD | RS | TE 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 |
Prescription |
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
|
BEXIMCO PHARMS USA |
202306 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
750MG |
Prescription |
No |
No |
AB |
2017/02/23
|
INTELLIPHARMACEUTICS |
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 |