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 | ROBINUL | GLYCOPYRROLATE | INJECTABLE;INJECTION | 0.2MG/ML | Yes | No | AP | 1975/02/06 | 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 |
|---|---|---|---|---|---|---|
| 1975/02/06 | ORIG-1（原始申请） | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|---|
| 2025/07/16 | SUPPL-68（补充） | Approval | Efficacy-New Indication | STANDARD | ||
| 2024/07/12 | SUPPL-63（补充） | Approval | Manufacturing (CMC)-Packaging | N/A | ||
| 2018/07/05 | SUPPL-62（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2014/03/18 | SUPPL-60（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2005/05/26 | SUPPL-53（补充） | Approval | Labeling | STANDARD | ||
| 2004/11/05 | SUPPL-50（补充） | Approval | Labeling | STANDARD | ||
| 2004/11/05 | SUPPL-49（补充） | Approval | Labeling | STANDARD | ||
| 2004/11/05 | SUPPL-46（补充） | Approval | Labeling | STANDARD | ||
| 2004/11/05 | SUPPL-45（补充） | Approval | Labeling | STANDARD | ||
| 2003/06/30 | SUPPL-48（补充） | Approval | Labeling | STANDARD | ||
| 2003/06/30 | SUPPL-47（补充） | Approval | Labeling | STANDARD | ||
| 2001/04/26 | SUPPL-43（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1998/02/13 | SUPPL-42（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1988/09/06 | SUPPL-41（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1988/06/06 | SUPPL-40（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1988/04/18 | SUPPL-39（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1987/03/16 | SUPPL-38（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1986/07/24 | SUPPL-35（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1986/06/12 | SUPPL-37（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1986/06/12 | SUPPL-36（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1983/03/02 | SUPPL-30（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1983/03/02 | SUPPL-29（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1982/03/04 | SUPPL-28（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/01/19 | SUPPL-27（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/11/06 | SUPPL-26（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1981/10/22 | SUPPL-24（补充） | Approval | Labeling | |||
| 1981/10/22 | SUPPL-23（补充） | Approval | Labeling | |||
| 1981/10/22 | SUPPL-22（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/09/24 | SUPPL-25（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/12/04 | SUPPL-18（补充） | Approval | Labeling | |||
| 1980/09/26 | SUPPL-19（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/04/01 | SUPPL-17（补充） | Approval | Labeling | |||
| 1980/04/01 | SUPPL-16（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/04/01 | SUPPL-15（补充） | Approval | Labeling | |||
| 1980/04/01 | SUPPL-14（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/11/30 | SUPPL-11（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/08/17 | SUPPL-10（补充） | Approval | Labeling | |||
| 1978/08/17 | SUPPL-9（补充） | Approval | Labeling | |||
| 1978/04/25 | SUPPL-8（补充） | Approval | Labeling | |||
| 1976/11/02 | SUPPL-4（补充） | Approval | Labeling | |||
| 1976/09/22 | SUPPL-3（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1975/11/05 | SUPPL-1（补充） | Approval | Labeling |
