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 | NOVOLIN N | INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | INJECTABLE;INJECTION | 100 UNITS/ML | No | No | None | 1991/07/01 | -- | 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
>>>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 |
|---|---|---|---|---|---|---|
| 1991/07/01 | ORIG-1（原始申请） | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|---|
| 2022/11/23 | SUPPL-85（补充） | Approval | Labeling-Patient Package Insert,Labeling-Package Insert,Labeling-Container/Carton Labels | STANDARD | ||
| 2019/11/15 | SUPPL-82（补充） | Approval | Labeling-Package Insert,Labeling-Patient Package Insert | 901 REQUIRED | ||
| 2018/06/01 | SUPPL-79（补充） | Approval | Labeling | STANDARD | ||
| 2018/06/01 | SUPPL-74（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2016/01/08 | SUPPL-77（补充） | Approval | Labeling-Container/Carton Labels | STANDARD | ||
| 2015/02/25 | SUPPL-75（补充） | Approval | Labeling-Container/Carton Labels | 901 REQUIRED | ||
| 2013/03/09 | SUPPL-73（补充） | Approval | Labeling-Patient Package Insert,Labeling-Package Insert | STANDARD | ||
| 2010/12/27 | SUPPL-70（补充） | Approval | Labeling | STANDARD | ||
| 2010/06/25 | SUPPL-71（补充） | Approval | Labeling-Container/Carton Labels | UNKNOWN | ||
| 2010/06/25 | SUPPL-69（补充） | Approval | Labeling-Container/Carton Labels | N/A | ||
| 2009/07/17 | SUPPL-67（补充） | Approval | Labeling-Package Insert,Labeling-Container/Carton Labels | N/A | ||
| 2009/06/15 | SUPPL-66（补充） | Approval | Labeling | STANDARD | ||
| 2002/06/19 | SUPPL-39（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2002/04/15 | SUPPL-35（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 2002/04/11 | SUPPL-34（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 2002/03/11 | SUPPL-31（补充） | Approval | Labeling | STANDARD | ||
| 2002/01/10 | SUPPL-38（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2001/12/19 | SUPPL-36（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 2001/12/17 | SUPPL-30（补充） | Approval | Labeling | STANDARD | ||
| 2001/02/21 | SUPPL-29（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2001/01/09 | SUPPL-33（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2000/12/13 | SUPPL-32（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2000/06/15 | SUPPL-28（补充） | Approval | Labeling | STANDARD | ||
| 2000/04/10 | SUPPL-27（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2000/03/16 | SUPPL-26（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1999/10/18 | SUPPL-25（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1998/07/24 | SUPPL-24（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1997/08/04 | SUPPL-23（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1997/06/20 | SUPPL-22（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1997/04/16 | SUPPL-21（补充） | Approval | Labeling | STANDARD | ||
| 1997/04/10 | SUPPL-19（补充） | Approval | Labeling | STANDARD | ||
| 1997/01/28 | SUPPL-17（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1997/01/02 | SUPPL-20（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/08/08 | SUPPL-18（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1995/05/22 | SUPPL-16（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1994/06/23 | SUPPL-13（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1994/06/23 | SUPPL-12（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1994/06/16 | SUPPL-11（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1994/05/31 | SUPPL-10（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1994/05/23 | SUPPL-9（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1994/04/26 | SUPPL-8（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1994/01/07 | SUPPL-7（补充） | Approval | Labeling | STANDARD | ||
| 1994/01/04 | SUPPL-15（补充） | Approval | Labeling | STANDARD | ||
| 1994/01/03 | SUPPL-14（补充） | Approval | Labeling | STANDARD | ||
| 1993/03/26 | SUPPL-6（补充） | Approval | Labeling | |||
| 1993/03/26 | SUPPL-4（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1992/03/13 | SUPPL-2（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1991/10/07 | SUPPL-1（补充） | Approval | Manufacturing (CMC)-Control | STANDARD |
