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 |
|---|
| 2019/09/05 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/09/05 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/07/19 |
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:AB3
| 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 |
|---|
| 021748 |
001 |
NDA |
GLUMETZA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
Yes |
No |
AB3 |
2005/06/03
|
SANTARUS INC |
| 091664 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB3 |
2013/07/19
|
LUPIN LTD |
| 202917 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB3 |
2016/08/01
|
SUN PHARM |
| 203755 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB3 |
2016/08/01
|
ACTAVIS LABS FL INC |
| 212969 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB3 |
2019/11/25
|
GLENMARK PHARMS LTD |
| 213344 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB3 |
2021/01/12
|
GRANULES |
| 213962 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB3 |
2021/03/09
|
AJANTA PHARMA LTD |
| 213334 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB3 |
2021/04/16
|
SCIEGEN PHARMS INC |
| 213356 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB3 |
2021/12/13
|
APOTEX |
| 212681 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB3 |
2022/06/09
|
PRINSTON INC |
| 212448 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB3 |
2023/01/10
|
MICRO LABS |
| 215629 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
500MG |
Prescription |
No |
No |
AB3 |
2023/06/20
|
RK 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:AB3
| 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 |
|---|
| 021748 |
002 |
NDA |
GLUMETZA |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
Yes |
Yes |
AB3 |
2005/06/03
|
SANTARUS INC |
| 091664 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2013/07/19
|
LUPIN LTD |
| 202917 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2016/08/01
|
SUN PHARM |
| 203755 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2016/08/01
|
ACTAVIS LABS FL INC |
| 212969 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2019/11/25
|
GLENMARK PHARMS LTD |
| 213344 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2021/01/12
|
GRANULES |
| 213962 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2021/03/09
|
AJANTA PHARMA LTD |
| 213334 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2021/04/16
|
SCIEGEN PHARMS INC |
| 213356 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2021/12/13
|
APOTEX |
| 212681 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2022/06/09
|
PRINSTON INC |
| 212448 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2023/01/10
|
MICRO LABS |
| 215629 |
002 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2023/06/20
|
RK PHARMA |
| 211163 |
001 |
ANDA |
METFORMIN HYDROCHLORIDE |
METFORMIN HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1GM |
Prescription |
No |
No |
AB3 |
2024/03/13
|
MACLEODS PHARMS LTD |
