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 |
|---|
| 2019/02/26 |
SUPPL-26（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/02/26 |
SUPPL-24（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2008/10/31 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 2007/05/25 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2005/04/12 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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: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 |