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 | ADVIL | IBUPROFEN | TABLET;ORAL | 200MG | Yes | Yes | None | 1984/05/18 | 1984/05/18 | 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 |
|---|---|---|---|---|---|---|
| 2021/12/14 | SUPPL-99（补充） | Approval | Labeling | STANDARD | ||
| 2020/04/10 | SUPPL-95（补充） | Approval | Manufacturing (CMC) | N/A | ||
| 2018/11/14 | SUPPL-91（补充） | Approval | Labeling | STANDARD | ||
| 2018/10/02 | SUPPL-90（补充） | Approval | Labeling | STANDARD | ||
| 2017/08/23 | SUPPL-88（补充） | Approval | Labeling | STANDARD | ||
| 2017/02/03 | SUPPL-87（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2016/04/29 | SUPPL-85（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2015/12/16 | SUPPL-84（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2015/05/18 | SUPPL-83（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2011/04/26 | SUPPL-79（补充） | Approval | Labeling | UNKNOWN | ||
| 2010/09/01 | SUPPL-80（补充） | Approval | Labeling | UNKNOWN | ||
| 2009/05/19 | SUPPL-73（补充） | Approval | Labeling | STANDARD | ||
| 2008/06/11 | SUPPL-70（补充） | Approval | Labeling | STANDARD | ||
| 2007/05/01 | SUPPL-67（补充） | Approval | Labeling | STANDARD | ||
| 2006/04/17 | SUPPL-60（补充） | Approval | Labeling | STANDARD | ||
| 2006/04/04 | SUPPL-61（补充） | Approval | Labeling | STANDARD | ||
| 2004/07/16 | SUPPL-58（补充） | Approval | Labeling | STANDARD | ||
| 2003/09/26 | SUPPL-56（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2002/04/24 | SUPPL-55（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2001/09/07 | SUPPL-53（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2001/08/02 | SUPPL-54（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2000/11/15 | SUPPL-52（补充） | Approval | Labeling | STANDARD | ||
| 1999/11/19 | SUPPL-50（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1999/10/04 | SUPPL-51（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1998/10/14 | SUPPL-49（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1997/04/03 | SUPPL-46（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1996/12/19 | SUPPL-48（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1996/12/03 | SUPPL-47（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1995/08/01 | SUPPL-43（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1995/04/04 | SUPPL-42（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1994/10/24 | SUPPL-40（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1994/09/07 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1994/03/11 | SUPPL-37（补充） | Approval | Labeling | |||
| 1994/03/11 | SUPPL-36（补充） | Approval | Labeling | |||
| 1993/10/18 | SUPPL-39（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1993/10/18 | SUPPL-38（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1993/02/26 | SUPPL-33（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1991/04/25 | SUPPL-31（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1991/04/25 | SUPPL-28（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1990/08/24 | SUPPL-34（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1989/06/28 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1989/02/14 | SUPPL-29（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1988/05/25 | SUPPL-26（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1988/05/25 | SUPPL-25（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1988/05/25 | SUPPL-23（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1988/05/25 | SUPPL-18（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1988/05/25 | SUPPL-16（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1988/05/02 | SUPPL-27（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1988/02/01 | SUPPL-17（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1987/01/17 | SUPPL-21（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1987/01/06 | SUPPL-22（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1986/07/05 | SUPPL-15（补充） | Approval | Labeling | |||
| 1986/05/30 | SUPPL-10（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1985/12/24 | SUPPL-14（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1985/10/19 | SUPPL-6（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1985/09/17 | SUPPL-5（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1984/12/18 | SUPPL-4（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1984/10/05 | SUPPL-7（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1984/05/18 | ORIG-1（原始申请） | Approval | Type 3 - New Dosage Form | PRIORITY |
