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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 002 | SLOW-K | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 8MEQ | No | No | None | 1975/04/25 | 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 |
|---|---|---|---|---|---|---|
| 1975/04/25 | ORIG-1（原始申请） | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|---|
| 2004/11/24 | SUPPL-45（补充） | Approval | Labeling | STANDARD | ||
| 2004/11/24 | SUPPL-44（补充） | Approval | Labeling | STANDARD | ||
| 1999/04/28 | SUPPL-43（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1996/11/22 | SUPPL-41（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1992/06/30 | SUPPL-40（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1991/05/20 | SUPPL-39（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1989/08/08 | SUPPL-38（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1988/03/23 | SUPPL-37（补充） | Approval | Labeling | |||
| 1986/10/31 | SUPPL-36（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/08/21 | SUPPL-35（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/03/19 | SUPPL-34（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/12/14 | SUPPL-33（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/05/22 | SUPPL-32（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1983/04/06 | SUPPL-30（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1982/10/22 | SUPPL-29（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1982/07/08 | SUPPL-17（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1982/07/02 | SUPPL-23（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1981/09/14 | SUPPL-28（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/09/14 | SUPPL-27（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1981/07/21 | SUPPL-26（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/04/07 | SUPPL-14（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/06/13 | SUPPL-25（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/01/21 | SUPPL-24（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1980/01/03 | SUPPL-18（补充） | Approval | Labeling | |||
| 1979/08/03 | SUPPL-21（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1979/08/03 | SUPPL-20（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1979/08/03 | SUPPL-19（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1979/06/29 | SUPPL-13（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1979/05/04 | SUPPL-22（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1978/01/09 | SUPPL-16（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1977/06/27 | SUPPL-15（补充） | Approval | Labeling | |||
| 1977/02/08 | SUPPL-12（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1977/02/08 | SUPPL-11（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1977/02/08 | SUPPL-10（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1976/06/29 | SUPPL-8（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/06/07 | SUPPL-9（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/04/01 | SUPPL-7（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1976/04/01 | SUPPL-4（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1976/01/09 | SUPPL-2（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1975/11/18 | SUPPL-3（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1975/08/20 | SUPPL-1（补充） | Approval | Manufacturing (CMC)-Control | STANDARD |
