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 | RIMACTANE | RIFAMPIN | CAPSULE;ORAL | 300MG | No | No | AB | 1971/05/21 | Approved Prior to Jan 1, 1982 | 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
| 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 |
|---|---|---|---|---|---|---|
| 2023/08/16 | SUPPL-87（补充） | Approval | Labeling | STANDARD | ||
| 2019/01/23 | SUPPL-86（补充） | Approval | Labeling | STANDARD | ||
| 2004/11/18 | SUPPL-83（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. | |
| 2001/03/01 | SUPPL-81（补充） | Approval | Manufacturing (CMC) | |||
| 2000/05/26 | SUPPL-80（补充） | Approval | Manufacturing (CMC) | |||
| 2000/05/26 | SUPPL-79（补充） | Approval | Manufacturing (CMC) | |||
| 1999/02/18 | SUPPL-78（补充） | Approval | Manufacturing (CMC) | |||
| 1998/10/30 | SUPPL-77（补充） | Approval | Manufacturing (CMC) | |||
| 1998/08/14 | SUPPL-76（补充） | Approval | Manufacturing (CMC) | |||
| 1997/04/07 | SUPPL-75（补充） | Approval | Manufacturing (CMC) | |||
| 1996/03/04 | SUPPL-74（补充） | Approval | Manufacturing (CMC) | |||
| 1995/03/27 | SUPPL-73（补充） | Approval | Manufacturing (CMC) | |||
| 1994/07/29 | SUPPL-71（补充） | Approval | Manufacturing (CMC) | |||
| 1994/06/06 | SUPPL-72（补充） | Approval | Manufacturing (CMC) | |||
| 1992/09/23 | SUPPL-70（补充） | Approval | Manufacturing (CMC) | |||
| 1992/08/24 | SUPPL-69（补充） | Approval | Manufacturing (CMC) | |||
| 1992/08/24 | SUPPL-68（补充） | Approval | Manufacturing (CMC) | |||
| 1992/08/24 | SUPPL-66（补充） | Approval | Manufacturing (CMC) | |||
| 1991/05/31 | SUPPL-67（补充） | Approval | Manufacturing (CMC) | |||
| 1990/02/23 | SUPPL-12（补充） | Approval | Manufacturing (CMC) | |||
| 1989/07/21 | SUPPL-11（补充） | Approval | Labeling | |||
| 1988/11/29 | SUPPL-10（补充） | Approval | Manufacturing (CMC) | |||
| 1988/11/29 | SUPPL-9（补充） | Approval | Manufacturing (CMC) | |||
| 1985/10/07 | SUPPL-8（补充） | Approval | Labeling | |||
| 1985/07/08 | SUPPL-7（补充） | Approval | Manufacturing (CMC) | |||
| 1985/05/29 | SUPPL-6（补充） | Approval | Manufacturing (CMC) | |||
| 1985/04/03 | SUPPL-5（补充） | Approval | Manufacturing (CMC) | |||
| 1984/09/25 | SUPPL-4（补充） | Approval | Manufacturing (CMC) | |||
| 1983/11/29 | SUPPL-3（补充） | Approval | Manufacturing (CMC) | |||
| 1983/09/13 | SUPPL-2（补充） | Approval | Manufacturing (CMC) | |||
| 1982/12/06 | SUPPL-1（补充） | Approval | Manufacturing (CMC) | |||
| 1982/09/28 | SUPPL-65（补充） | Approval | Manufacturing (CMC) | |||
| 1982/06/17 | SUPPL-64（补充） | Approval | Manufacturing (CMC) | |||
| 1981/12/10 | SUPPL-63（补充） | Approval | Manufacturing (CMC) | |||
| 1981/03/23 | SUPPL-62（补充） | Approval | Manufacturing (CMC) | |||
| 1980/07/02 | SUPPL-61（补充） | Approval | Manufacturing (CMC) | |||
| 1979/10/29 | SUPPL-60（补充） | Approval | Manufacturing (CMC) | |||
| 1979/08/21 | SUPPL-59（补充） | Approval | Manufacturing (CMC) | |||
| 1979/04/13 | SUPPL-58（补充） | Approval | Manufacturing (CMC) | |||
| 1979/01/22 | SUPPL-57（补充） | Approval | Manufacturing (CMC) | |||
| 1978/06/12 | SUPPL-55（补充） | Approval | Labeling | |||
| 1978/05/05 | SUPPL-53（补充） | Approval | Labeling | |||
| 1978/02/01 | SUPPL-52（补充） | Approval | Manufacturing (CMC) | |||
| 1977/09/27 | SUPPL-51（补充） | Approval | Manufacturing (CMC) | |||
| 1977/06/21 | SUPPL-50（补充） | Approval | Labeling | |||
| 1977/06/14 | SUPPL-49（补充） | Approval | Manufacturing (CMC) | |||
| 1977/06/01 | SUPPL-48（补充） | Approval | Manufacturing (CMC) | |||
| 1977/05/31 | SUPPL-47（补充） | Approval | Labeling | |||
| 1977/02/18 | SUPPL-46（补充） | Approval | Labeling | |||
| 1976/09/14 | SUPPL-45（补充） | Approval | Labeling | |||
| 1976/07/21 | SUPPL-44（补充） | Approval | Manufacturing (CMC) | |||
| 1976/05/26 | SUPPL-43（补充） | Approval | Manufacturing (CMC) | |||
| 1976/05/18 | SUPPL-42（补充） | Approval | Efficacy | |||
| 1976/03/26 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | |||
| 1975/12/09 | SUPPL-40（补充） | Approval | Manufacturing (CMC) | |||
| 1975/08/22 | SUPPL-39（补充） | Approval | Manufacturing (CMC) | |||
| 1974/12/09 | SUPPL-38（补充） | Approval | Manufacturing (CMC) | |||
| 1974/09/30 | SUPPL-37（补充） | Approval | Manufacturing (CMC) | |||
| 1974/09/18 | SUPPL-36（补充） | Approval | Manufacturing (CMC) | |||
| 1974/03/28 | SUPPL-35（补充） | Approval | Manufacturing (CMC) | |||
| 1974/01/24 | SUPPL-34（补充） | Approval | Labeling | |||
| 1974/01/16 | SUPPL-33（补充） | Approval | Manufacturing (CMC) | |||
| 1973/12/04 | SUPPL-32（补充） | Approval | Labeling | |||
| 1973/10/26 | SUPPL-28（补充） | Approval | Manufacturing (CMC) | |||
| 1973/10/09 | SUPPL-31（补充） | Approval | Labeling | |||
| 1973/10/04 | SUPPL-30（补充） | Approval | Labeling | |||
| 1973/10/04 | SUPPL-27（补充） | Approval | Labeling | |||
| 1973/05/09 | SUPPL-29（补充） | Approval | Efficacy | |||
| 1973/01/30 | SUPPL-26（补充） | Approval | Manufacturing (CMC) | |||
| 1973/01/05 | SUPPL-25（补充） | Approval | Labeling | |||
| 1972/10/03 | SUPPL-24（补充） | Approval | Labeling | |||
| 1972/08/10 | SUPPL-23（补充） | Approval | Manufacturing (CMC) | |||
| 1972/07/14 | SUPPL-22（补充） | Approval | Manufacturing (CMC) | |||
| 1972/06/29 | SUPPL-21（补充） | Approval | Manufacturing (CMC) | |||
| 1972/05/17 | SUPPL-20（补充） | Approval | Manufacturing (CMC) | |||
| 1972/04/13 | SUPPL-19（补充） | Approval | Manufacturing (CMC) | |||
| 1972/02/22 | SUPPL-18（补充） | Approval | Manufacturing (CMC) | |||
| 1972/01/14 | SUPPL-17（补充） | Approval | Manufacturing (CMC) | |||
| 1971/08/13 | SUPPL-16（补充） | Approval | Manufacturing (CMC) | |||
| 1971/08/06 | SUPPL-15（补充） | Approval | Manufacturing (CMC) | |||
| 1971/06/28 | SUPPL-14（补充） | Approval | Labeling | |||
| 1971/05/24 | SUPPL-13（补充） | Approval | Manufacturing (CMC) | |||
| 1971/05/21 | ORIG-1（原始申请） | Approval | UNKNOWN |
