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 |
|---|
| 2024/07/08 |
SUPPL-72（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/10/06 |
SUPPL-70（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/12/15 |
SUPPL-69（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/03/05 |
SUPPL-68（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/04/03 |
SUPPL-67（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/07/13 |
SUPPL-66（补充） |
Approval |
Labeling |
STANDARD
|
|
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| 2013/08/16 |
SUPPL-65（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/08/19 |
SUPPL-61（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2004/03/17 |
SUPPL-59（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/04/23 |
SUPPL-58（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1996/05/07 |
SUPPL-53（补充） |
Approval |
Labeling |
|
|
|
| 1996/05/07 |
SUPPL-51（补充） |
Approval |
Labeling |
|
|
|
| 1996/05/07 |
SUPPL-49（补充） |
Approval |
Labeling |
|
|
|
| 1996/05/07 |
SUPPL-48（补充） |
Approval |
Labeling |
|
|
|
| 1994/02/16 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1992/06/23 |
SUPPL-54（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1990/07/30 |
SUPPL-52（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1989/04/13 |
SUPPL-50（补充） |
Approval |
Labeling |
|
|
|
| 1989/02/03 |
SUPPL-47（补充） |
Approval |
Labeling |
|
|
|
| 1988/02/10 |
SUPPL-41（补充） |
Approval |
Efficacy |
|
|
|
| 1987/12/28 |
SUPPL-45（补充） |
Approval |
Labeling |
|
|
|
| 1987/11/03 |
SUPPL-40（补充） |
Approval |
Labeling |
|
|
|
| 1987/08/21 |
SUPPL-38（补充） |
Approval |
Labeling |
|
|
|
| 1987/06/18 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1986/07/22 |
SUPPL-44（补充） |
Approval |
Labeling |
|
|
|
| 1984/03/30 |
SUPPL-37（补充） |
Approval |
Labeling |
|
|
|
| 1983/10/18 |
SUPPL-35（补充） |
Approval |
Labeling |
|
|
|
| 1983/10/18 |
SUPPL-34（补充） |
Approval |
Labeling |
|
|
|
| 1983/06/02 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1982/05/05 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1982/02/04 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1981/08/13 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1981/08/04 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1980/12/12 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1980/12/08 |
SUPPL-27（补充） |
Approval |
Labeling |
|
|
|
| 1980/02/27 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1980/01/09 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1980/01/02 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1979/07/26 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 1979/04/19 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1979/03/02 |
SUPPL-23（补充） |
Approval |
Labeling |
|
|
|
| 1977/08/22 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 1976/10/05 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1975/11/05 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 1974/05/14 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 1974/05/14 |
SUPPL-12（补充） |
Approval |
Supplement |
PRIORITY
|
|
|
| 1963/07/18 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 |
|---|
| 012623 |
001 |
NDA |
FLAGYL |
METRONIDAZOLE |
TABLET;ORAL |
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
PFIZER |
活性成分:METRONIDAZOLE 剂型/给药途径:TABLET;ORAL 规格:500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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 |
|---|
| 012623 |
003 |
NDA |
FLAGYL |
METRONIDAZOLE |
TABLET;ORAL |
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
PFIZER |
