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 |
|---|
| 2016/03/07 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2012/08/01 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
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:AB2
| 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 |
|---|
| 090692 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB2 |
2011/06/29
|
LUPIN LTD |
| 200690 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB2 |
2012/08/01
|
MYLAN PHARMS INC |
| 203832 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB2 |
2017/12/26
|
NOSTRUM LABS INC |
| 209674 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB2 |
2018/11/02
|
NOVAST LABS |
| 209993 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB2 |
2018/12/27
|
QINGDAO BAHEAL PHARM |
| 213651 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB2 |
2020/04/09
|
AJANTA PHARMA LTD |
| 213247 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB2 |
2021/09/29
|
TWI PHARMS |
| 214629 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB2 |
2022/02/22
|
SCIEGEN PHARMS INC |
| 209694 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB2 |
2024/10/18
|
AUROBINDO PHARMA |
活性成分:METFORMIN HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:1GM 治疗等效代码:AB2
| 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 |
|---|
| 021574 |
002 |
NDA |
FORTAMET |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
Yes |
No |
AB2 |
2004/04/27
|
ANDRX LABS LLC |
| 090692 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
Yes |
AB2 |
2011/06/29
|
LUPIN LTD |
| 200690 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB2 |
2012/08/01
|
MYLAN PHARMS INC |
| 203832 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB2 |
2017/12/26
|
NOSTRUM LABS INC |
| 209674 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB2 |
2018/11/02
|
NOVAST LABS |
| 209993 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB2 |
2018/12/27
|
QINGDAO BAHEAL PHARM |
| 213651 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB2 |
2020/04/09
|
AJANTA PHARMA LTD |
| 213247 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB2 |
2021/09/29
|
TWI PHARMS |
| 214629 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB2 |
2022/02/22
|
SCIEGEN PHARMS INC |
| 209694 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB2 |
2024/10/18
|
AUROBINDO PHARMA |