产品信息
| 产品号 | 商品名 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 参比药物(RLD) | 生物等效参考标准(RS) | 治疗等效代码 | 该申请号批准日期 | 该产品号批准日期 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|
| 002 | MONISTAT 7 | MICONAZOLE NITRATE | CREAM;VAGINAL | 2% | Yes | Yes | None | 1974/01/30 | 1991/02/15 | Over-the-counter |
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 |
|---|---|---|---|---|---|---|
| 2020/07/22 | SUPPL-75（补充） | Approval | Manufacturing (CMC) | N/A | ||
| 2020/01/28 | SUPPL-73（补充） | Approval | Labeling | STANDARD | ||
| 2015/08/10 | SUPPL-68（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2014/03/10 | SUPPL-67（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2014/02/27 | SUPPL-66（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2013/08/13 | SUPPL-64（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2013/07/10 | SUPPL-63（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2013/01/29 | SUPPL-62（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2009/11/05 | SUPPL-56（补充） | Approval | Manufacturing (CMC) | N/A | ||
| 2008/08/21 | SUPPL-55（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2002/10/28 | SUPPL-51（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2002/08/07 | SUPPL-52（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2002/04/10 | SUPPL-50（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2001/05/16 | SUPPL-49（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1999/10/04 | SUPPL-47（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1999/02/04 | SUPPL-46（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1999/02/03 | SUPPL-45（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1998/03/17 | SUPPL-44（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1997/03/21 | SUPPL-43（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1995/03/06 | SUPPL-42（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1995/02/09 | SUPPL-40（补充） | Approval | Labeling | STANDARD | ||
| 1993/09/03 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1993/04/26 | SUPPL-38（补充） | Approval | Efficacy | |||
| 1992/10/08 | SUPPL-39（补充） | Approval | Labeling | STANDARD | ||
| 1992/06/03 | SUPPL-37（补充） | Approval | Labeling | |||
| 1991/02/15 | SUPPL-35（补充） | Approval | Efficacy | |||
| 1990/03/09 | SUPPL-34（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1986/08/26 | SUPPL-32（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1986/07/22 | SUPPL-31（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1986/07/22 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1985/07/05 | SUPPL-29（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1985/06/27 | SUPPL-28（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1984/06/12 | SUPPL-27（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1984/05/29 | SUPPL-26（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1983/06/02 | SUPPL-25（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1982/09/17 | SUPPL-24（补充） | Approval | Labeling | |||
| 1982/09/17 | SUPPL-20（补充） | Approval | Labeling | |||
| 1982/09/15 | SUPPL-22（补充） | Approval | Labeling | |||
| 1982/05/13 | SUPPL-23（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1982/04/19 | SUPPL-21（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1980/04/03 | SUPPL-16（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1979/09/13 | SUPPL-12（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1979/06/29 | SUPPL-15（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1979/06/14 | SUPPL-14（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1979/06/14 | SUPPL-13（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1979/03/23 | SUPPL-10（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1978/09/12 | SUPPL-11（补充） | Approval | Labeling | |||
| 1978/04/25 | SUPPL-9（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1977/12/22 | SUPPL-7（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1977/08/02 | SUPPL-6（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1977/08/02 | SUPPL-5（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1977/07/28 | SUPPL-3（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1976/04/21 | SUPPL-2（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/01/30 | ORIG-1（原始申请） | Approval | Type 1 - New Molecular Entity | STANDARD |
