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 | BREVICON 28-DAY | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG;0.5MG | No | No | None | 1976/03/29 | Approved Prior to Jan 1, 1982 | Discontinued |
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 |
|---|---|---|---|---|---|---|
| 2017/10/10 | SUPPL-89（补充） | Approval | Labeling | STANDARD | ||
| 2017/08/09 | SUPPL-88（补充） | Approval | Labeling | STANDARD | ||
| 2001/08/15 | SUPPL-75（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2000/02/14 | SUPPL-73（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2000/01/24 | SUPPL-74（补充） | Approval | Labeling | STANDARD | ||
| 1999/02/04 | SUPPL-72（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1997/07/30 | SUPPL-71（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1995/08/30 | SUPPL-69（补充） | Approval | Labeling | STANDARD | ||
| 1994/12/13 | SUPPL-70（补充） | Approval | Labeling | STANDARD | ||
| 1994/02/04 | SUPPL-67（补充） | Approval | Labeling | |||
| 1992/07/31 | SUPPL-68（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1990/11/02 | SUPPL-63（补充） | Approval | Labeling | |||
| 1990/09/19 | SUPPL-66（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1989/10/20 | SUPPL-65（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1989/02/22 | SUPPL-64（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1987/10/26 | SUPPL-45（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/07/17 | SUPPL-61（补充） | Approval | Labeling | |||
| 1985/10/25 | SUPPL-60（补充） | Approval | Labeling | |||
| 1985/04/16 | SUPPL-59（补充） | Approval | Labeling | |||
| 1984/11/13 | SUPPL-57（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/09/27 | SUPPL-53（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/07/30 | SUPPL-56（补充） | Approval | Labeling | |||
| 1984/06/12 | SUPPL-55（补充） | Approval | Labeling | |||
| 1984/05/16 | SUPPL-44（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/05/07 | SUPPL-52（补充） | Approval | Labeling | |||
| 1984/03/06 | SUPPL-48（补充） | Approval | Labeling | |||
| 1983/07/26 | SUPPL-51（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1983/07/26 | SUPPL-47（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1983/07/19 | SUPPL-50（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1983/07/19 | SUPPL-49（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1983/06/13 | SUPPL-46（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/07/29 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/01/11 | SUPPL-38（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/12/18 | SUPPL-34（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/12/18 | SUPPL-33（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/10/14 | SUPPL-3（补充） | Approval | Labeling | |||
| 1980/06/23 | SUPPL-31（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1979/07/18 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1979/07/18 | SUPPL-27（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/11/06 | SUPPL-22（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/11/06 | SUPPL-21（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/05/26 | SUPPL-19（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1977/07/01 | SUPPL-4（补充） | Approval | Labeling | |||
| 1977/06/14 | SUPPL-8（补充） | Approval | Labeling | |||
| 1977/06/14 | SUPPL-7（补充） | Approval | Labeling | |||
| 1976/03/29 | ORIG-1（原始申请） | Approval | Type 3 - New Dosage Form | STANDARD |
