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 | MODICON 28 | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-28 | 0.035MG;0.5MG | Yes | No | None | 1976/05/14 | 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
>>>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 |
|---|---|---|---|---|---|---|
| 1976/05/14 | 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 |
|---|---|---|---|---|---|---|
| 2017/08/09 | SUPPL-118（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2015/10/29 | SUPPL-117（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2014/09/11 | SUPPL-116（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2013/10/03 | SUPPL-104（补充） | Approval | Labeling | STANDARD | ||
| 2013/10/02 | SUPPL-114（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2013/10/02 | SUPPL-110（补充） | Approval | Labeling | STANDARD | ||
| 2013/10/02 | SUPPL-108（补充） | Approval | Labeling | STANDARD | ||
| 2012/06/18 | SUPPL-107（补充） | Approval | Labeling | STANDARD | ||
| 2002/06/03 | SUPPL-93（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2002/02/21 | SUPPL-92（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2001/07/09 | SUPPL-91（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 2000/06/06 | SUPPL-89（补充） | Approval | Labeling | STANDARD | ||
| 2000/01/05 | SUPPL-88（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1999/08/27 | SUPPL-87（补充） | Approval | Labeling | STANDARD | ||
| 1999/08/27 | SUPPL-83（补充） | Approval | Labeling | STANDARD | ||
| 1999/01/06 | SUPPL-84（补充） | Approval | Labeling | STANDARD | ||
| 1998/04/28 | SUPPL-86（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1998/04/13 | SUPPL-85（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1997/02/24 | SUPPL-82（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1997/01/29 | SUPPL-81（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/05/10 | SUPPL-79（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1996/04/09 | SUPPL-80（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1995/11/30 | SUPPL-78（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1995/09/07 | SUPPL-77（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1995/02/16 | SUPPL-76（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1994/03/07 | SUPPL-72（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1994/01/04 | SUPPL-74（补充） | Approval | Labeling | STANDARD | ||
| 1993/11/04 | SUPPL-75（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1993/05/18 | SUPPL-73（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1991/09/16 | SUPPL-69（补充） | Approval | Labeling | |||
| 1991/03/18 | SUPPL-70（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1990/01/18 | SUPPL-68（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1989/10/23 | SUPPL-66（补充） | Approval | Labeling | |||
| 1989/07/19 | SUPPL-65（补充） | Approval | Labeling | |||
| 1988/10/28 | SUPPL-64（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1988/09/08 | SUPPL-62（补充） | Approval | Labeling | |||
| 1988/06/08 | SUPPL-63（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1987/11/23 | SUPPL-60（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1987/02/26 | SUPPL-61（补充） | Approval | Labeling | |||
| 1985/10/21 | SUPPL-58（补充） | Approval | Labeling | |||
| 1985/04/05 | SUPPL-57（补充） | Approval | Labeling | |||
| 1984/06/21 | SUPPL-56（补充） | Approval | Labeling | |||
| 1984/01/30 | SUPPL-55（补充） | Approval | Labeling | |||
| 1983/09/29 | SUPPL-54（补充） | Approval | Labeling | |||
| 1983/06/15 | SUPPL-52（补充） | Approval | Labeling | |||
| 1983/06/09 | SUPPL-51（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1982/09/29 | SUPPL-49（补充） | Approval | Labeling | |||
| 1980/11/20 | SUPPL-46（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/11/20 | SUPPL-45（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1980/08/21 | SUPPL-43（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/03/28 | SUPPL-42（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1980/03/24 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/03/24 | SUPPL-33（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/11/13 | SUPPL-40（补充） | Approval | Labeling | |||
| 1979/11/08 | SUPPL-39（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1979/10/19 | SUPPL-36（补充） | Approval | Manufacturing (CMC)-Packaging | STANDARD | ||
| 1979/08/15 | SUPPL-37（补充） | Approval | Labeling | |||
| 1979/06/19 | SUPPL-23（补充） | Approval | Manufacturing (CMC)-Formulation | STANDARD | ||
| 1979/05/07 | SUPPL-38（补充） | Approval | Manufacturing (CMC)-Expiration Date | STANDARD | ||
| 1978/07/31 | SUPPL-5（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/06/07 | SUPPL-32（补充） | Approval | Labeling | |||
| 1978/05/25 | SUPPL-14（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/04/17 | SUPPL-16（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/03/29 | SUPPL-8（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/02/28 | SUPPL-19（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/02/28 | SUPPL-18（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1978/02/28 | SUPPL-17（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1977/10/20 | SUPPL-9（补充） | Approval | Manufacturing (CMC)-Control | STANDARD | ||
| 1977/07/15 | SUPPL-2（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1977/07/01 | SUPPL-3（补充） | Approval | Labeling | |||
| 1976/12/30 | SUPPL-1（补充） | Approval | Manufacturing (CMC)-Control | STANDARD |
