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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 002 | BLEPHAMIDE | PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM | SUSPENSION;OPHTHALMIC | 0.2%;10% | Yes | No | None | 1961/09/18 | 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 |
|---|---|---|---|---|---|---|
| 2017/07/18 | SUPPL-62（补充） | Approval | Labeling | STANDARD | ||
| 2003/03/19 | SUPPL-57（补充） | Approval | Labeling | STANDARD | ||
| 2002/04/12 | SUPPL-54（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2001/12/04 | SUPPL-53（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2001/04/12 | SUPPL-52（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2001/03/26 | SUPPL-51（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2000/10/02 | SUPPL-50（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2000/04/21 | SUPPL-49（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2000/04/21 | SUPPL-48（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1999/12/03 | SUPPL-47（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1998/08/03 | SUPPL-43（补充） | Approval | Labeling | STANDARD | ||
| 1998/08/03 | SUPPL-29（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1998/05/21 | SUPPL-45（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1998/01/09 | SUPPL-46（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1997/09/30 | SUPPL-44（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1996/12/02 | SUPPL-42（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1995/08/03 | SUPPL-40（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1994/06/22 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1993/04/13 | SUPPL-39（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1990/08/06 | SUPPL-38（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1989/11/07 | SUPPL-37（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1989/03/14 | SUPPL-36（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/11/10 | SUPPL-35（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/07/18 | SUPPL-33（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/07/07 | SUPPL-32（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/03/14 | SUPPL-34（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/08/23 | SUPPL-31（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/07/09 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/09/15 | SUPPL-24（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/09/15 | SUPPL-23（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/09/25 | SUPPL-25（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/05/08 | SUPPL-21（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/11/07 | SUPPL-20（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1961/09/18 | ORIG-1（原始申请） | Approval | Type 4 - New Combination | STANDARD |
