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 | HALOG | HALCINONIDE | CREAM;TOPICAL | 0.1% | Yes | Yes | AB | 1974/11/27 | 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
>>>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 |
|---|---|---|---|---|---|---|
| 1974/11/27 | ORIG-1（原始申请） | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|---|
| 2014/04/02 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2009/06/10 | SUPPL-38（补充） | Approval | Labeling-Package Insert,Labeling-Container/Carton Labels | N/A | ||
| 2004/09/29 | SUPPL-34（补充） | Approval | Labeling | STANDARD | ||
| 1990/06/29 | SUPPL-33（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1989/06/27 | SUPPL-32（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1989/03/23 | SUPPL-31（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1987/11/03 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/05/27 | SUPPL-29（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/04/22 | SUPPL-28（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1985/07/30 | SUPPL-27（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/01/28 | SUPPL-26（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1984/05/24 | SUPPL-25（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1982/11/26 | SUPPL-23（补充） | Approval | Labeling | |||
| 1982/03/18 | SUPPL-24（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1980/05/20 | SUPPL-22（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1980/03/24 | SUPPL-21（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/02/13 | SUPPL-19（补充） | Approval | Labeling | |||
| 1979/02/02 | SUPPL-18（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1979/01/10 | SUPPL-17（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/06/07 | SUPPL-16（补充） | Approval | Labeling | |||
| 1978/06/07 | SUPPL-15（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1978/04/19 | SUPPL-13（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1978/01/09 | SUPPL-12（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1977/08/24 | SUPPL-11（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1977/03/08 | SUPPL-8（补充） | Approval | Labeling | |||
| 1976/02/09 | SUPPL-7（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1975/05/07 | SUPPL-3（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1975/04/04 | SUPPL-4（补充） | Approval | Labeling |
