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 | PARAGARD T 380A | COPPER | SYSTEM;INTRAUTERINE | 309MG/COPPER | Yes | Yes | None | 1984/11/15 | 1984/11/15 | 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 |
|---|---|---|---|---|---|---|
| 1984/11/15 | 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 |
|---|---|---|---|---|---|---|
| 2024/06/28 | SUPPL-74（补充） | Approval | Efficacy-Labeling Change With Clinical Data | STANDARD | ||
| 2019/09/05 | SUPPL-70（补充） | Approval | Labeling-Container/Carton Labels | STANDARD | ||
| 2019/09/05 | SUPPL-69（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2014/02/20 | SUPPL-68（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/06/11 | SUPPL-66（补充） | Approval | Labeling-Patient Package Insert | UNKNOWN | ||
| 2005/09/01 | SUPPL-60（补充） | Approval | Efficacy-Labeling Change With Clinical Data | UNKNOWN | ||
| 2003/04/22 | SUPPL-57（补充） | Approval | Labeling | STANDARD | ||
| 2001/09/27 | SUPPL-56（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2001/08/24 | SUPPL-55（补充） | Approval | Labeling | STANDARD | ||
| 2000/09/20 | SUPPL-54（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2000/04/25 | SUPPL-53（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2000/03/27 | SUPPL-52（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1999/12/14 | SUPPL-51（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1999/07/23 | SUPPL-50（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1999/07/23 | SUPPL-49（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1999/02/02 | SUPPL-48（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1999/02/02 | SUPPL-47（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1998/07/07 | SUPPL-44（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1998/07/07 | SUPPL-43（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1998/05/29 | SUPPL-46（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1998/05/29 | SUPPL-45（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1998/02/10 | SUPPL-42（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1997/11/03 | SUPPL-41（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1997/10/09 | SUPPL-40（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1997/06/04 | SUPPL-39（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1997/03/13 | SUPPL-38（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1997/02/14 | SUPPL-37（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/05/17 | SUPPL-36（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/04/12 | SUPPL-35（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/04/12 | SUPPL-34（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/01/24 | SUPPL-32（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/01/18 | SUPPL-33（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1995/07/24 | SUPPL-31（补充） | Approval | Labeling | STANDARD | ||
| 1995/07/24 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1994/05/19 | SUPPL-26（补充） | Approval | Efficacy-New Dosing Regimen | STANDARD | ||
| 1993/06/17 | SUPPL-25（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1991/11/25 | SUPPL-23（补充） | Approval | Labeling | |||
| 1991/11/25 | SUPPL-20（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1991/11/25 | SUPPL-19（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1991/11/25 | SUPPL-14（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1991/11/20 | SUPPL-21（补充） | Approval | Labeling | |||
| 1991/08/13 | SUPPL-16（补充） | Approval | Efficacy-New Dosing Regimen | |||
| 1991/07/17 | SUPPL-17（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1991/05/03 | SUPPL-15（补充） | Approval | Labeling | |||
| 1991/03/22 | SUPPL-13（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1990/09/24 | SUPPL-12（补充） | Approval | Labeling | |||
| 1989/07/24 | SUPPL-11（补充） | Approval | Labeling | |||
| 1989/07/24 | SUPPL-10（补充） | Approval | Labeling | |||
| 1989/07/17 | SUPPL-8（补充） | Approval | Efficacy-New Dosing Regimen | |||
| 1989/03/01 | SUPPL-9（补充） | Approval | Labeling | |||
| 1988/11/18 | SUPPL-5（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1988/10/17 | SUPPL-6（补充） | Approval | Labeling | |||
| 1988/04/29 | SUPPL-3（补充） | Approval | Labeling |