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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 001 | COLGATE TOTAL | SODIUM FLUORIDE; TRICLOSAN | PASTE;DENTAL | 0.24%;0.3% | Yes | No | None | 1997/07/11 | 1997/07/11 | Discontinued |
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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|---|---|---|---|---|---|
| 1997/07/11 | ORIG-1（原始申请） | Approval | Type 4 - New Combination | STANDARD |
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|---|---|---|---|---|---|
| 2016/03/24 | SUPPL-75（补充） | Approval | Labeling-Container/Carton Labels | STANDARD | ||
| 2015/12/21 | SUPPL-74（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/06/11 | SUPPL-73（补充） | Approval | Labeling-Container/Carton Labels | STANDARD | ||
| 2014/06/11 | SUPPL-72（补充） | Approval | Labeling-Container/Carton Labels | STANDARD | ||
| 2013/04/12 | SUPPL-71（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2010/09/15 | SUPPL-58（补充） | Approval | Efficacy-Manufacturing Change With Clinical Data,Labeling-Container/Carton Labels | STANDARD | ||
| 2009/02/20 | SUPPL-64（补充） | Approval | Labeling | STANDARD | ||
| 2007/12/03 | SUPPL-60（补充） | Approval | Labeling-Container/Carton Labels | N/A | ||
| 2007/11/09 | SUPPL-53（补充） | Approval | Labeling-Container/Carton Labels | N/A | ||
| 2007/11/09 | SUPPL-52（补充） | Approval | Labeling-Container/Carton Labels | N/A | ||
| 2007/10/17 | SUPPL-57（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 2007/09/18 | SUPPL-56（补充） | Approval | Labeling-Container/Carton Labels | N/A | ||
| 2007/09/10 | SUPPL-55（补充） | Approval | Labeling-Container/Carton Labels | N/A | ||
| 2007/03/20 | SUPPL-47（补充） | Approval | Labeling-Container/Carton Labels | N/A | ||
| 2007/03/19 | SUPPL-50（补充） | Approval | Labeling-Package Insert,Labeling-Container/Carton Labels | N/A | ||
| 2006/09/15 | SUPPL-46（补充） | Approval | Labeling-Container/Carton Labels | N/A | ||
| 2006/04/21 | SUPPL-43（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 2005/11/10 | SUPPL-42（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2005/08/03 | SUPPL-41（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 2005/02/02 | SUPPL-37（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 2004/04/13 | SUPPL-33（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 2003/10/24 | SUPPL-32（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 2003/10/09 | SUPPL-28（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 2003/04/10 | SUPPL-29（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 2002/12/06 | SUPPL-27（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 2002/12/06 | SUPPL-26（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 2002/06/05 | SUPPL-25（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2002/05/07 | SUPPL-24（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2002/04/30 | SUPPL-23（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 2001/12/10 | SUPPL-22（补充） | Approval | Labeling | STANDARD | ||
| 2001/09/13 | SUPPL-20（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2001/08/01 | SUPPL-21（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 2001/02/08 | SUPPL-12（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2000/12/12 | SUPPL-19（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2000/05/12 | SUPPL-16（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 2000/03/31 | SUPPL-15（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 2000/02/28 | SUPPL-14（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1999/09/02 | SUPPL-10（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1999/08/04 | SUPPL-11（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1999/07/12 | SUPPL-9（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1999/02/25 | SUPPL-7（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1998/12/28 | SUPPL-8（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1998/12/22 | SUPPL-1（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1998/06/10 | SUPPL-3（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1998/06/09 | SUPPL-5（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1998/05/29 | SUPPL-2（补充） | Approval | Manufacturing (CMC) | STANDARD |
