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 | INTRALIPID 10% | SOYBEAN OIL | INJECTABLE;INJECTION | 10% | Yes | No | AP | 1975/10/07 | Approved Prior to Jan 1, 1982 | 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 |
|---|---|---|---|---|---|---|
| 1975/10/07 | 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 |
|---|---|---|---|---|---|---|
| 2025/07/24 | SUPPL-85（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2023/05/17 | SUPPL-83（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2022/05/03 | SUPPL-82（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2018/07/25 | SUPPL-78（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2016/12/01 | SUPPL-76（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2016/05/31 | SUPPL-77（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2016/04/21 | SUPPL-75（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/12/15 | SUPPL-74（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2007/04/24 | SUPPL-72（补充） | Approval | Labeling | STANDARD | ||
| 2004/04/16 | SUPPL-70（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2001/08/22 | SUPPL-65（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2000/12/20 | SUPPL-60（补充） | Approval | Labeling | STANDARD | ||
| 2000/09/27 | SUPPL-64（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1999/07/21 | SUPPL-63（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1999/03/18 | SUPPL-62（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1997/04/29 | SUPPL-61（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1995/02/17 | SUPPL-59（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1994/05/18 | SUPPL-55（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1993/08/24 | SUPPL-56（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1991/11/08 | SUPPL-57（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1990/06/20 | SUPPL-53（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1990/06/06 | SUPPL-54（补充） | Approval | Labeling | |||
| 1989/04/10 | SUPPL-52（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1988/09/19 | SUPPL-45（补充） | Approval | Labeling | |||
| 1985/01/31 | SUPPL-48（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/01/29 | SUPPL-49（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/07/27 | SUPPL-47（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/05/02 | SUPPL-46（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/02/10 | SUPPL-33（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1983/06/07 | SUPPL-40（补充） | Approval | Labeling | |||
| 1983/05/27 | SUPPL-43（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1983/05/27 | SUPPL-42（补充） | Approval | Labeling | |||
| 1982/01/27 | SUPPL-39（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/06/20 | SUPPL-36（补充） | Approval | Labeling | |||
| 1981/06/17 | SUPPL-37（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/07/11 | SUPPL-31（补充） | Approval | Labeling | |||
| 1980/05/14 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/02/26 | SUPPL-25（补充） | Approval | Labeling | |||
| 1980/01/02 | SUPPL-19（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/12/14 | SUPPL-27（补充） | Approval | Labeling | |||
| 1979/12/14 | SUPPL-24（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1979/10/23 | SUPPL-20（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/10/15 | SUPPL-29（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/10/15 | SUPPL-26（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/09/28 | SUPPL-28（补充） | Approval | Labeling | |||
| 1979/09/07 | SUPPL-21（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/08/16 | SUPPL-23（补充） | Approval | Labeling | |||
| 1979/07/09 | SUPPL-22（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/04/25 | SUPPL-14（补充） | Approval | Labeling | |||
| 1979/04/25 | SUPPL-13（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/04/09 | SUPPL-18（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/04/09 | SUPPL-17（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/01/30 | SUPPL-16（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/11/08 | SUPPL-15（补充） | Approval | Labeling | |||
| 1978/09/06 | SUPPL-8（补充） | Approval | Labeling | |||
| 1978/09/06 | SUPPL-7（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/08/28 | SUPPL-5（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/07/10 | SUPPL-9（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/03/15 | SUPPL-6（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/03/06 | SUPPL-10（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1977/12/28 | SUPPL-11（补充） | Approval | Labeling | |||
| 1977/03/28 | SUPPL-3（补充） | Approval | Labeling |
