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 | RIFADIN | RIFAMPIN | CAPSULE;ORAL | 300MG | Yes | No | None | 1971/05/21 | 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 |
|---|---|---|---|---|---|---|
| 2024/10/10 | SUPPL-92（补充） | Approval | Labeling | STANDARD | ||
| 2023/12/08 | SUPPL-91（补充） | Approval | Labeling | STANDARD | ||
| 2023/08/16 | SUPPL-90（补充） | Approval | Labeling | STANDARD | ||
| 2023/02/17 | SUPPL-89（补充） | Approval | Labeling | STANDARD | ||
| 2023/02/10 | SUPPL-88（补充） | Approval | Labeling | STANDARD | ||
| 2022/01/29 | SUPPL-87（补充） | Approval | Labeling | STANDARD | ||
| 2021/10/21 | SUPPL-86（补充） | Approval | Labeling | STANDARD | ||
| 2021/06/17 | SUPPL-85（补充） | Approval | Labeling | STANDARD | ||
| 2020/05/12 | SUPPL-84（补充） | Approval | Labeling | STANDARD | ||
| 2019/08/27 | SUPPL-83（补充） | Approval | Labeling | STANDARD | ||
| 2019/02/28 | SUPPL-80（补充） | Approval | Labeling | STANDARD | ||
| 2019/01/23 | SUPPL-78（补充） | Approval | Labeling | STANDARD | ||
| 2018/01/08 | SUPPL-77（补充） | Approval | Labeling | STANDARD | ||
| 2017/04/24 | SUPPL-76（补充） | Approval | Labeling | STANDARD | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | |
| 2013/02/27 | SUPPL-75（补充） | Approval | Labeling | STANDARD | ||
| 2010/11/10 | SUPPL-73（补充） | Approval | Labeling | STANDARD | ||
| 2004/08/20 | SUPPL-72（补充） | Approval | Labeling | STANDARD | ||
| 2000/04/12 | SUPPL-71（补充） | Approval | Labeling | STANDARD | ||
| 2000/04/12 | SUPPL-70（补充） | Approval | Labeling | STANDARD | ||
| 1996/09/17 | SUPPL-67（补充） | Approval | Labeling | STANDARD | ||
| 1996/01/05 | SUPPL-64（补充） | Approval | Manufacturing (CMC) | |||
| 1995/09/05 | SUPPL-68（补充） | Approval | Manufacturing (CMC) | |||
| 1994/07/12 | SUPPL-66（补充） | Approval | Manufacturing (CMC) | |||
| 1993/06/18 | SUPPL-63（补充） | Approval | Labeling | |||
| 1990/02/12 | SUPPL-9（补充） | Approval | Manufacturing (CMC) | |||
| 1990/02/12 | SUPPL-7（补充） | Approval | Labeling | |||
| 1989/05/18 | SUPPL-13（补充） | Approval | Manufacturing (CMC) | |||
| 1987/11/16 | SUPPL-14（补充） | Approval | Manufacturing (CMC) | |||
| 1986/02/18 | SUPPL-11（补充） | Approval | Manufacturing (CMC) | |||
| 1984/09/12 | SUPPL-12（补充） | Approval | Labeling | |||
| 1984/02/08 | SUPPL-10（补充） | Approval | Manufacturing (CMC) | |||
| 1983/09/02 | SUPPL-8（补充） | Approval | Labeling | |||
| 1982/11/17 | SUPPL-5（补充） | Approval | Manufacturing (CMC) | |||
| 1982/11/15 | SUPPL-4（补充） | Approval | Manufacturing (CMC) | |||
| 1982/11/15 | SUPPL-3（补充） | Approval | Manufacturing (CMC) | |||
| 1982/10/26 | SUPPL-2（补充） | Approval | Manufacturing (CMC) | |||
| 1982/10/05 | SUPPL-1（补充） | Approval | Manufacturing (CMC) | |||
| 1982/09/11 | SUPPL-59（补充） | Approval | Manufacturing (CMC) | |||
| 1982/03/22 | SUPPL-18（补充） | Approval | Labeling | |||
| 1981/10/20 | SUPPL-61（补充） | Approval | Manufacturing (CMC) | |||
| 1981/10/20 | SUPPL-60（补充） | Approval | Labeling | |||
| 1980/12/31 | SUPPL-58（补充） | Approval | Manufacturing (CMC) | |||
| 1980/07/25 | SUPPL-57（补充） | Approval | Manufacturing (CMC) | |||
| 1979/10/29 | SUPPL-56（补充） | Approval | Manufacturing (CMC) | |||
| 1979/10/25 | SUPPL-55（补充） | Approval | Manufacturing (CMC) | |||
| 1979/07/25 | SUPPL-54（补充） | Approval | Labeling | |||
| 1979/06/26 | SUPPL-49（补充） | Approval | Labeling | |||
| 1979/05/01 | SUPPL-53（补充） | Approval | Labeling | |||
| 1979/04/16 | SUPPL-52（补充） | Approval | Labeling | |||
| 1979/04/16 | SUPPL-51（补充） | Approval | Manufacturing (CMC) | |||
| 1979/03/23 | SUPPL-50（补充） | Approval | Labeling | |||
| 1978/06/29 | SUPPL-48（补充） | Approval | Labeling | |||
| 1978/05/30 | SUPPL-47（补充） | Approval | Labeling | |||
| 1978/02/10 | SUPPL-46（补充） | Approval | Labeling | |||
| 1977/06/29 | SUPPL-45（补充） | Approval | Labeling | |||
| 1977/05/25 | SUPPL-6（补充） | Approval | Manufacturing (CMC) | |||
| 1976/12/21 | SUPPL-44（补充） | Approval | Labeling | |||
| 1976/08/09 | SUPPL-43（补充） | Approval | Manufacturing (CMC) | |||
| 1976/08/03 | SUPPL-42（补充） | Approval | Manufacturing (CMC) | |||
| 1976/03/29 | SUPPL-37（补充） | Approval | Labeling | |||
| 1976/03/01 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | |||
| 1976/02/18 | SUPPL-40（补充） | Approval | Labeling | |||
| 1976/01/28 | SUPPL-39（补充） | Approval | Labeling | |||
| 1976/01/19 | SUPPL-38（补充） | Approval | Labeling | |||
| 1975/10/15 | SUPPL-35（补充） | Approval | Manufacturing (CMC) | |||
| 1975/09/16 | SUPPL-34（补充） | Approval | Labeling | |||
| 1975/08/28 | SUPPL-36（补充） | Approval | Manufacturing (CMC) | |||
| 1975/01/30 | SUPPL-33（补充） | Approval | Labeling | |||
| 1974/11/26 | SUPPL-32（补充） | Approval | Labeling | |||
| 1974/05/29 | SUPPL-30（补充） | Approval | Labeling | |||
| 1974/05/21 | SUPPL-31（补充） | Approval | Labeling | |||
| 1974/03/28 | SUPPL-29（补充） | Approval | Manufacturing (CMC) | |||
| 1974/03/28 | SUPPL-28（补充） | Approval | Labeling | |||
| 1974/01/24 | SUPPL-27（补充） | Approval | Labeling | |||
| 1973/11/20 | SUPPL-25（补充） | Approval | Labeling | |||
| 1973/10/11 | SUPPL-26（补充） | Approval | Labeling | |||
| 1973/05/09 | SUPPL-24（补充） | Approval | Manufacturing (CMC) | |||
| 1973/01/19 | SUPPL-23（补充） | Approval | Labeling | |||
| 1972/10/05 | SUPPL-22（补充） | Approval | Manufacturing (CMC) | |||
| 1972/09/25 | SUPPL-21（补充） | Approval | Labeling | |||
| 1972/08/31 | SUPPL-20（补充） | Approval | Manufacturing (CMC) | |||
| 1972/06/16 | SUPPL-19（补充） | Approval | Manufacturing (CMC) | |||
| 1972/01/26 | SUPPL-17（补充） | Approval | Labeling | |||
| 1971/12/06 | SUPPL-16（补充） | Approval | Manufacturing (CMC) | |||
| 1971/08/09 | SUPPL-15（补充） | Approval | Labeling | |||
| 1971/05/21 | ORIG-1（原始申请） | Approval | UNKNOWN |
