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 |
|---|
| 2024/10/25 |
SUPPL-25（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/07/08 |
SUPPL-22（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/11/22 |
SUPPL-19（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/03/31 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/08/19 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/08/14 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/08/14 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/01/22 |
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:METRONIDAZOLE 剂型/给药途径:TABLET;ORAL 规格:250MG 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 |
|---|
| 070027 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
1984/11/06
|
TEVA PHARMS USA |
| 070035 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
1984/12/20
|
WATSON LABS |
| 070040 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
1985/01/29
|
STRIDES PHARMA |
| 070772 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
1986/07/16
|
INNOGENIX |
| 079067 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2009/03/13
|
ALEMBIC PHARMS LTD |
| 203458 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2014/01/22
|
UNICHEM |
| 203974 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2015/05/29
|
AUROBINDO PHARMA LTD |
| 205245 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2015/09/23
|
APPCO |
| 207309 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Discontinued |
No |
No |
AB |
2016/05/16
|
FLAMINGO PHARMS |
| 208162 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2016/05/25
|
ESJAY PHARMA |
| 206560 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2016/11/16
|
CADILA |
| 208681 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2017/06/20
|
ALEMBIC |
| 209096 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2017/09/12
|
LUPIN LTD |
| 209794 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2017/12/12
|
CADILA PHARMS LTD |
活性成分:METRONIDAZOLE 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 |
|---|
| 070033 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
1984/12/06
|
PLIVA |
| 070039 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
1985/01/29
|
STRIDES PHARMA |
| 070044 |
001 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
1985/02/08
|
WATSON LABS INC |
| 070772 |
002 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
1986/07/16
|
INNOGENIX |
| 079067 |
002 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2009/03/13
|
ALEMBIC PHARMS LTD |
| 203458 |
002 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2014/01/22
|
UNICHEM |
| 203974 |
002 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
Yes |
AB |
2015/05/29
|
AUROBINDO PHARMA LTD |
| 205245 |
002 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2015/09/23
|
APPCO |
| 207309 |
002 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Discontinued |
No |
No |
AB |
2016/05/16
|
FLAMINGO PHARMS |
| 208162 |
002 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2016/05/25
|
ESJAY PHARMA |
| 206560 |
002 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2016/11/16
|
CADILA |
| 208681 |
002 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2017/06/20
|
ALEMBIC |
| 209096 |
002 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2017/09/12
|
LUPIN LTD |
| 209794 |
002 |
ANDA |
METRONIDAZOLE |
METRONIDAZOLE |
TABLET;ORAL |
500MG |
Prescription |
No |
No |
AB |
2017/12/12
|
CADILA PHARMS LTD |