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 | HUMULIN N | INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | INJECTABLE;INJECTION | 100 UNITS/ML | No | No | None | 1982/10/28 | -- | 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 |
|---|---|---|---|---|---|---|
| 1982/10/28 | ORIG-1（原始申请） | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|---|
| 2022/06/27 | SUPPL-193（补充） | Approval | Labeling-Package Insert,Labeling-Container/Carton Labels,Labeling-Patient Package Insert | STANDARD | ||
| 2019/11/15 | SUPPL-188（补充） | Approval | Labeling-Package Insert | 901 REQUIRED | ||
| 2019/11/15 | SUPPL-187（补充） | Approval | Labeling-Container/Carton Labels,Labeling-Package Insert | STANDARD | ||
| 2019/08/22 | SUPPL-184（补充） | Approval | Labeling-Container/Carton Labels,Labeling-Patient Package Insert,Labeling-Package Insert | STANDARD | ||
| 2018/11/06 | SUPPL-181（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2017/01/06 | SUPPL-167（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2016/04/22 | SUPPL-161（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2016/04/05 | SUPPL-163（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2016/02/19 | SUPPL-160（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2015/10/20 | SUPPL-159（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2015/10/08 | SUPPL-158（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2015/07/15 | SUPPL-157（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2015/03/12 | SUPPL-156（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2015/03/03 | SUPPL-155（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2015/02/25 | SUPPL-154（补充） | Approval | Labeling-Patient Package Insert,Labeling-Container/Carton Labels | 901 REQUIRED | ||
| 2015/01/12 | SUPPL-153（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/09/30 | SUPPL-120（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/09/12 | SUPPL-150（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/06/10 | SUPPL-146（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/06/04 | SUPPL-147（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/04/11 | SUPPL-143（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/04/03 | SUPPL-142（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/03/18 | SUPPL-140（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/03/04 | SUPPL-139（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/01/24 | SUPPL-141（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/01/15 | SUPPL-145（补充） | Approval | Labeling-Container/Carton Labels | STANDARD | ||
| 2013/12/12 | SUPPL-137（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/12/09 | SUPPL-144（补充） | Approval | Labeling-Container/Carton Labels | STANDARD | ||
| 2013/11/07 | SUPPL-122（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2013/11/07 | SUPPL-118（补充） | Approval | Labeling-Container/Carton Labels | UNKNOWN | ||
| 2013/08/21 | SUPPL-132（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/08/15 | SUPPL-136（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/06/12 | SUPPL-126（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/05/31 | SUPPL-134（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/05/30 | SUPPL-133（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/05/10 | SUPPL-129（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/03/25 | SUPPL-130（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/03/09 | SUPPL-121（补充） | Approval | Labeling | UNKNOWN | ||
| 2013/02/21 | SUPPL-131（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/02/15 | SUPPL-128（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2012/12/03 | SUPPL-125（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2012/03/21 | SUPPL-113（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2010/06/10 | SUPPL-114（补充） | Approval | Labeling-Patient Package Insert | UNKNOWN | ||
| 2009/03/16 | SUPPL-108（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2007/09/07 | SUPPL-88（补充） | Approval | Labeling | STANDARD | ||
| 2007/08/22 | SUPPL-89（补充） | Approval | Labeling | STANDARD | ||
| 2005/11/09 | SUPPL-85（补充） | Approval | Labeling | STANDARD | ||
| 2005/02/25 | SUPPL-80（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2004/09/03 | SUPPL-79（补充） | Approval | Labeling | STANDARD | ||
| 2004/04/21 | SUPPL-76（补充） | Approval | Labeling | STANDARD | ||
| 2003/11/20 | SUPPL-70（补充） | Approval | Labeling | STANDARD | ||
| 2003/11/20 | SUPPL-60（补充） | Approval | Labeling | STANDARD | ||
| 2003/11/19 | SUPPL-74（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2003/06/22 | SUPPL-72（补充） | Approval | Labeling | STANDARD | ||
| 2003/02/12 | SUPPL-57（补充） | Approval | Labeling | STANDARD | ||
| 2002/11/05 | SUPPL-54（补充） | Approval | Labeling | STANDARD | ||
| 2002/10/31 | SUPPL-62（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2002/08/29 | SUPPL-67（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2002/08/29 | SUPPL-66（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2002/08/29 | SUPPL-65（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2002/08/21 | SUPPL-64（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2002/08/21 | SUPPL-63（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2002/04/02 | SUPPL-61（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2000/07/07 | SUPPL-56（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1999/10/29 | SUPPL-55（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1999/02/25 | SUPPL-53（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1998/08/06 | SUPPL-50（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1998/02/20 | SUPPL-48（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1997/06/24 | SUPPL-49（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1997/04/16 | SUPPL-47（补充） | Approval | Labeling | STANDARD | ||
| 1997/01/28 | SUPPL-46（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1996/07/26 | SUPPL-43（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/07/10 | SUPPL-44（补充） | Approval | Labeling | STANDARD | ||
| 1996/05/31 | SUPPL-41（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/05/22 | SUPPL-42（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/02/15 | SUPPL-39（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/01/26 | SUPPL-40（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1995/11/09 | SUPPL-38（补充） | Approval | Labeling | STANDARD | ||
| 1995/10/27 | SUPPL-33（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1995/09/29 | SUPPL-37（补充） | Approval | Labeling | STANDARD | ||
| 1995/03/09 | SUPPL-36（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1995/02/22 | SUPPL-35（补充） | Approval | Labeling | |||
| 1995/02/10 | SUPPL-34（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1994/01/11 | SUPPL-31（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1992/12/07 | SUPPL-32（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1991/04/03 | SUPPL-27（补充） | Approval | Labeling | |||
| 1991/03/12 | SUPPL-30（补充） | Approval | Labeling | |||
| 1990/09/24 | SUPPL-29（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1990/08/17 | SUPPL-28（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1989/01/23 | SUPPL-26（补充） | Approval | Labeling | |||
| 1988/07/29 | SUPPL-25（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1988/06/28 | SUPPL-13（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1988/03/24 | SUPPL-23（补充） | Approval | Labeling | |||
| 1988/03/03 | SUPPL-24（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1987/10/27 | SUPPL-22（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1987/10/27 | SUPPL-21（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1987/10/27 | SUPPL-20（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1987/10/27 | SUPPL-15（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1987/07/31 | SUPPL-14（补充） | Approval | Labeling | |||
| 1987/07/28 | SUPPL-16（补充） | Approval | Labeling | |||
| 1987/07/13 | SUPPL-18（补充） | Approval | Labeling | |||
| 1987/07/13 | SUPPL-17（补充） | Approval | Labeling | |||
| 1987/07/10 | SUPPL-19（补充） | Approval | Labeling | |||
| 1985/02/14 | SUPPL-9（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/12/26 | SUPPL-10（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/07/25 | SUPPL-7（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/02/29 | SUPPL-8（补充） | Approval | Labeling | |||
| 1983/10/12 | SUPPL-6（补充） | Approval | Labeling | |||
| 1983/08/24 | SUPPL-5（补充） | Approval | Labeling | |||
| 1983/01/31 | SUPPL-3（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1983/01/27 | SUPPL-4（补充） | Approval | Labeling | |||
| 1982/12/02 | SUPPL-2（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1982/12/02 | SUPPL-1（补充） | Approval | Labeling |
