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 | TALWIN | PENTAZOCINE LACTATE | INJECTABLE;INJECTION | EQ 30MG BASE/ML | Yes | No | None | 1967/07/24 | 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 |
|---|---|---|---|---|---|---|
| 1967/07/24 | ORIG-1（原始申请） | Approval | Type 1 - New Molecular Entity | PRIORITY |
>>>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 |
|---|---|---|---|---|---|---|
| 2019/10/07 | SUPPL-81（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2016/12/16 | SUPPL-80（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2016/12/16 | SUPPL-79（补充） | Approval | Labeling-Package Insert,Labeling-Package Insert | STANDARD | ||
| 2004/05/27 | SUPPL-68（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 2001/09/26 | SUPPL-65（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 2001/01/31 | SUPPL-64（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 2000/06/27 | SUPPL-63（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 2000/05/24 | SUPPL-62（补充） | Approval | Labeling | STANDARD | ||
| 1998/10/22 | SUPPL-61（补充） | Approval | Efficacy-Labeling Change With Clinical Data | STANDARD | ||
| 1995/10/10 | SUPPL-60（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1993/04/21 | SUPPL-59（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1992/09/29 | SUPPL-58（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1990/01/25 | SUPPL-57（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1989/09/22 | SUPPL-55（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1989/08/23 | SUPPL-56（补充） | Approval | Labeling | |||
| 1988/05/04 | SUPPL-53（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1988/03/30 | SUPPL-52（补充） | Approval | Labeling | |||
| 1985/07/15 | SUPPL-49（补充） | Approval | Manufacturing (CMC)-Expiration Date | PRIORITY | ||
| 1983/09/01 | SUPPL-47（补充） | Approval | Manufacturing (CMC)-Packaging | PRIORITY | ||
| 1983/08/24 | SUPPL-48（补充） | Approval | Manufacturing (CMC)-Packaging | PRIORITY | ||
| 1983/05/18 | SUPPL-45（补充） | Approval | Labeling | |||
| 1981/10/09 | SUPPL-40（补充） | Approval | Labeling | |||
| 1981/09/29 | SUPPL-43（补充） | Approval | Labeling | |||
| 1981/08/07 | SUPPL-42（补充） | Approval | Manufacturing (CMC)-Formulation | PRIORITY | ||
| 1981/03/18 | SUPPL-44（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1980/11/05 | SUPPL-41（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1979/04/09 | SUPPL-39（补充） | Approval | Labeling | |||
| 1978/09/14 | SUPPL-37（补充） | Approval | Labeling | |||
| 1978/07/21 | SUPPL-36（补充） | Approval | Labeling | |||
| 1978/07/18 | SUPPL-38（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1978/02/22 | SUPPL-32（补充） | Approval | Labeling | |||
| 1977/12/16 | SUPPL-34（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1977/12/15 | SUPPL-31（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1977/12/02 | SUPPL-33（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1977/01/04 | SUPPL-35（补充） | Approval | Manufacturing (CMC)-Formulation | PRIORITY | ||
| 1976/07/16 | SUPPL-28（补充） | Approval | Labeling | |||
| 1976/06/07 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1976/03/26 | SUPPL-27（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1976/03/26 | SUPPL-18（补充） | Approval | Manufacturing (CMC)-Control | PRIORITY | ||
| 1975/10/23 | SUPPL-25（补充） | Approval | Labeling | |||
| 1974/10/25 | SUPPL-24（补充） | Approval | Labeling | |||
| 1974/02/06 | SUPPL-21（补充） | Approval | Labeling |
