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 | STERILE WATER | STERILE WATER FOR IRRIGATION | LIQUID;IRRIGATION | 100% | Yes | No | AT | 1974/12/31 | 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
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 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 |
|---|---|---|---|---|---|---|
| 2017/10/17 | SUPPL-71（补充） | Approval | Labeling | STANDARD | ||
| 2016/08/04 | SUPPL-73（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2011/09/28 | SUPPL-69（补充） | Approval | Manufacturing (CMC) | |||
| 1994/09/30 | SUPPL-58（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1993/09/14 | SUPPL-59（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1991/11/14 | SUPPL-56（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1991/03/26 | SUPPL-57（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1990/05/18 | SUPPL-55（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1989/07/26 | SUPPL-54（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/10/30 | SUPPL-53（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/04/06 | SUPPL-52（补充） | Approval | Labeling | |||
| 1985/01/24 | SUPPL-48（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/01/24 | SUPPL-40（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/02/28 | SUPPL-50（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/12/22 | SUPPL-45（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/12/22 | SUPPL-44（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/12/22 | SUPPL-43（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/06/07 | SUPPL-46（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/04/09 | SUPPL-34（补充） | Approval | Labeling | |||
| 1982/04/09 | SUPPL-33（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/04/09 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/03/01 | SUPPL-31（补充） | Approval | Labeling | |||
| 1982/02/16 | SUPPL-42（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/08/06 | SUPPL-38（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/06/29 | SUPPL-37（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/06/10 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/02/23 | SUPPL-36（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/01/22 | SUPPL-35（补充） | Approval | Labeling | |||
| 1980/07/31 | SUPPL-32（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/06/02 | SUPPL-28（补充） | Approval | Labeling | |||
| 1980/06/02 | SUPPL-27（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1979/12/19 | SUPPL-29（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1979/12/11 | SUPPL-20（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1979/12/11 | SUPPL-19（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1979/12/11 | SUPPL-13（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1979/05/29 | SUPPL-26（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1979/03/14 | SUPPL-24（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1979/02/14 | SUPPL-22（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1979/02/08 | SUPPL-25（补充） | Approval | Labeling | |||
| 1978/06/20 | SUPPL-21（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1977/10/05 | SUPPL-17（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1977/09/20 | SUPPL-12（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1977/07/12 | SUPPL-16（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1977/07/12 | SUPPL-15（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1977/04/26 | SUPPL-14（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/12/17 | SUPPL-9（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/11/10 | SUPPL-8（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/11/10 | SUPPL-7（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/10/06 | SUPPL-11（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/10/06 | SUPPL-6（补充） | Approval | Labeling | |||
| 1976/09/28 | SUPPL-4（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/09/02 | SUPPL-5（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/08/18 | SUPPL-3（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/06/16 | SUPPL-10（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1975/07/07 | SUPPL-1（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1974/12/31 | ORIG-1（原始申请） | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
