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 | TEGRETOL | CARBAMAZEPINE | TABLET;ORAL | 200MG | Yes | Yes | AB | 1968/03/11 | Approved Prior to Jan 1, 1982 | Prescription |
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 |
|---|---|---|---|---|---|---|
| 2023/09/13 | SUPPL-121（补充） | Approval | Labeling | STANDARD | ||
| 2018/03/20 | SUPPL-116（补充） | Approval | Labeling | STANDARD | ||
| 2015/10/30 | SUPPL-111（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2015/08/28 | SUPPL-97（补充） | Approval | Labeling | STANDARD | ||
| 2014/09/16 | SUPPL-99（补充） | Approval | Labeling | STANDARD | ||
| 2014/01/16 | SUPPL-103（补充） | Approval | Labeling | UNKNOWN | ||
| 2013/11/08 | SUPPL-108（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2013/03/06 | SUPPL-105（补充） | Approval | Labeling | STANDARD | ||
| 2012/12/11 | SUPPL-107（补充） | Approval | Labeling | STANDARD | ||
| 2011/10/30 | SUPPL-106（补充） | Approval | REMS | N/A | ||
| 2011/03/03 | SUPPL-102（补充） | Approval | Labeling | STANDARD | ||
| 2011/03/03 | SUPPL-100（补充） | Approval | Labeling | STANDARD | ||
| 2009/04/23 | SUPPL-101（补充） | Approval | Labeling | 901 REQUIRED | ||
| 2007/12/11 | SUPPL-98（补充） | Approval | Labeling | STANDARD | ||
| 2007/08/16 | SUPPL-96（补充） | Approval | Labeling | STANDARD | ||
| 2002/01/28 | SUPPL-94（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2001/11/19 | SUPPL-92（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2001/11/15 | SUPPL-93（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2001/03/07 | SUPPL-90（补充） | Approval | Labeling | STANDARD | ||
| 2000/05/18 | SUPPL-91（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2000/04/11 | SUPPL-89（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2000/04/10 | SUPPL-88（补充） | Approval | Labeling | STANDARD | ||
| 2000/04/10 | SUPPL-84（补充） | Approval | Labeling | STANDARD | ||
| 1999/06/07 | SUPPL-87（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1999/04/21 | SUPPL-86（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1998/07/15 | SUPPL-85（补充） | Approval | Labeling | STANDARD | ||
| 1998/07/15 | SUPPL-83（补充） | Approval | Labeling | STANDARD | ||
| 1998/07/15 | SUPPL-81（补充） | Approval | Labeling | STANDARD | ||
| 1998/07/15 | SUPPL-80（补充） | Approval | Labeling | STANDARD | ||
| 1997/03/06 | SUPPL-82（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1995/10/11 | SUPPL-59（补充） | Approval | Efficacy | |||
| 1995/10/05 | SUPPL-79（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1993/10/06 | SUPPL-77（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1991/03/14 | SUPPL-71（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1990/06/01 | SUPPL-70（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1990/03/28 | SUPPL-66（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1990/03/28 | SUPPL-65（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1990/03/27 | SUPPL-64（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1990/03/26 | SUPPL-68（补充） | Approval | Labeling | |||
| 1989/07/21 | SUPPL-63（补充） | Approval | Labeling | |||
| 1989/04/07 | SUPPL-62（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1988/08/08 | SUPPL-60（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1988/08/01 | SUPPL-61（补充） | Approval | Labeling | |||
| 1987/07/31 | SUPPL-58（补充） | Approval | Labeling | |||
| 1987/07/31 | SUPPL-48（补充） | Approval | Efficacy | |||
| 1986/06/02 | SUPPL-54（补充） | Approval | Efficacy | |||
| 1986/02/03 | SUPPL-56（补充） | Approval | Labeling | |||
| 1986/01/10 | SUPPL-55（补充） | Approval | Labeling | |||
| 1986/01/10 | SUPPL-53（补充） | Approval | Labeling | |||
| 1985/05/06 | SUPPL-52（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1985/03/08 | SUPPL-51（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1984/07/31 | SUPPL-50（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1983/09/14 | SUPPL-49（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1982/07/08 | SUPPL-47（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1982/02/09 | SUPPL-46（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1981/12/08 | SUPPL-45（补充） | Approval | Labeling | |||
| 1980/03/25 | SUPPL-42（补充） | Approval | Labeling | |||
| 1980/02/01 | SUPPL-43（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1979/04/09 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1978/11/22 | SUPPL-39（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1978/11/22 | SUPPL-38（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1978/08/09 | SUPPL-37（补充） | Approval | Labeling | |||
| 1978/08/09 | SUPPL-36（补充） | Approval | Labeling | |||
| 1977/04/04 | SUPPL-35（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1977/04/04 | SUPPL-34（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1977/04/04 | SUPPL-33（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1976/11/08 | SUPPL-28（补充） | Approval | Labeling | |||
| 1975/12/12 | SUPPL-32（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1975/12/09 | SUPPL-29（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1975/07/02 | SUPPL-27（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1975/03/31 | SUPPL-26（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1975/03/28 | SUPPL-23（补充） | Approval | Labeling | |||
| 1974/12/12 | SUPPL-25（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/11/15 | SUPPL-24（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/11/08 | SUPPL-21（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/08/29 | SUPPL-20（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/08/29 | SUPPL-19（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/08/29 | SUPPL-18（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/08/29 | SUPPL-17（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/08/29 | SUPPL-16（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/08/29 | SUPPL-15（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/08/29 | SUPPL-14（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/08/20 | SUPPL-22（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1974/07/15 | SUPPL-12（补充） | Approval | Labeling | |||
| 1968/03/11 | ORIG-1（原始申请） | Approval | Type 1 - New Molecular Entity | PRIORITY |
