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 | AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER | GLYCINE | SOLUTION;IRRIGATION | 1.5GM/100ML | Yes | Yes | AT | 1980/05/30 | 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 |
|---|---|---|---|---|---|---|
| 1980/05/30 | 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 |
|---|---|---|---|---|---|---|
| 2014/09/26 | SUPPL-48（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2006/02/21 | SUPPL-45（补充） | Approval | Labeling | STANDARD | ||
| 2002/09/03 | SUPPL-41（补充） | Approval | Labeling | STANDARD | ||
| 2002/09/03 | SUPPL-40（补充） | Approval | Labeling | STANDARD | ||
| 2002/07/17 | SUPPL-38（补充） | Approval | Labeling | STANDARD | ||
| 2001/08/14 | SUPPL-42（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1999/11/24 | SUPPL-39（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1997/04/29 | SUPPL-37（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1994/09/30 | SUPPL-35（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1994/02/18 | SUPPL-36（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1993/12/08 | SUPPL-34（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1991/05/08 | SUPPL-31（补充） | Approval | Labeling | |||
| 1991/04/26 | SUPPL-32（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1991/03/26 | SUPPL-30（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1991/02/15 | SUPPL-29（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1989/07/26 | SUPPL-28（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1989/01/12 | SUPPL-27（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/08/28 | SUPPL-21（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/08/28 | SUPPL-20（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/06/13 | SUPPL-24（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/04/15 | SUPPL-25（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1985/01/24 | SUPPL-18（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/03/16 | SUPPL-19（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1984/02/28 | SUPPL-23（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1982/12/22 | SUPPL-14（补充） | Approval | Labeling | |||
| 1982/12/22 | SUPPL-13（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1982/06/03 | SUPPL-10（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1982/04/16 | SUPPL-9（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1982/02/17 | SUPPL-16（补充） | Approval | Labeling | |||
| 1981/12/21 | SUPPL-8（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/11/20 | SUPPL-12（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/11/13 | SUPPL-7（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/06/29 | SUPPL-5（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/05/29 | SUPPL-4（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1981/01/21 | SUPPL-3（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/08/06 | SUPPL-2（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/07/31 | SUPPL-1（补充） | Approval | Manufacturing (CMC)-Control | STANDARD |
