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 | VIBRAMYCIN | DOXYCYCLINE | FOR SUSPENSION;ORAL | EQ 25MG BASE/5ML | Yes | Yes | AB | 1967/12/06 | 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 |
|---|---|---|---|---|---|---|
| 2019/12/20 | SUPPL-92（补充） | Approval | Labeling | STANDARD | ||
| 2018/12/03 | SUPPL-91（补充） | Approval | Labeling | STANDARD | ||
| 2017/07/26 | SUPPL-89（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. | |
| 2016/12/21 | SUPPL-88（补充） | Approval | Labeling | STANDARD | ||
| 2016/03/31 | SUPPL-87（补充） | Approval | Labeling | STANDARD | ||
| 2014/09/12 | SUPPL-86（补充） | Approval | Labeling | STANDARD | ||
| 2013/09/04 | SUPPL-85（补充） | Approval | Labeling | STANDARD | ||
| 2013/04/29 | SUPPL-84（补充） | Approval | Labeling | STANDARD | ||
| 2011/05/11 | SUPPL-82（补充） | Approval | Labeling | STANDARD | ||
| 2008/02/06 | SUPPL-79（补充） | Approval | Labeling | STANDARD | ||
| 2004/03/12 | SUPPL-76（补充） | Approval | Labeling | STANDARD | ||
| 2002/06/18 | SUPPL-74（补充） | Approval | Labeling | STANDARD | ||
| 1992/12/15 | SUPPL-73（补充） | Approval | Efficacy | |||
| 1992/05/11 | SUPPL-7（补充） | Approval | Labeling | |||
| 1992/05/11 | SUPPL-5（补充） | Approval | Labeling | |||
| 1991/08/23 | SUPPL-4（补充） | Approval | Labeling | |||
| 1983/11/21 | SUPPL-2（补充） | Approval | Labeling | |||
| 1983/03/29 | SUPPL-1（补充） | Approval | Labeling | |||
| 1982/08/31 | SUPPL-72（补充） | Approval | Labeling | |||
| 1981/10/20 | SUPPL-70（补充） | Approval | Manufacturing (CMC) | |||
| 1981/10/19 | SUPPL-71（补充） | Approval | Manufacturing (CMC) | |||
| 1980/09/17 | SUPPL-69（补充） | Approval | Manufacturing (CMC) | |||
| 1980/09/16 | SUPPL-68（补充） | Approval | Manufacturing (CMC) | |||
| 1980/08/12 | SUPPL-67（补充） | Approval | Labeling | |||
| 1979/09/20 | SUPPL-65（补充） | Approval | Manufacturing (CMC) | |||
| 1979/09/19 | SUPPL-66（补充） | Approval | Manufacturing (CMC) | |||
| 1978/10/19 | SUPPL-64（补充） | Approval | Manufacturing (CMC) | |||
| 1978/07/12 | SUPPL-63（补充） | Approval | Labeling | |||
| 1978/07/12 | SUPPL-62（补充） | Approval | Labeling | |||
| 1978/03/13 | SUPPL-61（补充） | Approval | Labeling | |||
| 1977/09/21 | SUPPL-59（补充） | Approval | Manufacturing (CMC) | |||
| 1977/09/20 | SUPPL-60（补充） | Approval | Labeling | |||
| 1977/09/14 | SUPPL-58（补充） | Approval | Manufacturing (CMC) | |||
| 1976/12/06 | SUPPL-57（补充） | Approval | Manufacturing (CMC) | |||
| 1976/09/13 | SUPPL-56（补充） | Approval | Manufacturing (CMC) | |||
| 1976/09/10 | SUPPL-55（补充） | Approval | Manufacturing (CMC) | |||
| 1976/05/20 | SUPPL-54（补充） | Approval | Manufacturing (CMC) | |||
| 1976/04/09 | SUPPL-53（补充） | Approval | Manufacturing (CMC) | |||
| 1976/01/15 | SUPPL-52（补充） | Approval | Labeling | |||
| 1975/12/01 | SUPPL-51（补充） | Approval | Manufacturing (CMC) | |||
| 1975/09/16 | SUPPL-48（补充） | Approval | Manufacturing (CMC) | |||
| 1975/09/03 | SUPPL-50（补充） | Approval | Manufacturing (CMC) | |||
| 1975/09/03 | SUPPL-49（补充） | Approval | Manufacturing (CMC) | |||
| 1975/04/18 | SUPPL-47（补充） | Approval | Labeling | |||
| 1974/09/24 | SUPPL-46（补充） | Approval | Manufacturing (CMC) | |||
| 1974/09/24 | SUPPL-45（补充） | Approval | Manufacturing (CMC) | |||
| 1974/06/21 | SUPPL-44（补充） | Approval | Manufacturing (CMC) | |||
| 1974/06/06 | SUPPL-43（补充） | Approval | Labeling | |||
| 1974/04/16 | SUPPL-42（补充） | Approval | Labeling | |||
| 1973/10/30 | SUPPL-39（补充） | Approval | Labeling | |||
| 1973/10/30 | SUPPL-38（补充） | Approval | Labeling | |||
| 1973/10/30 | SUPPL-37（补充） | Approval | Labeling | |||
| 1973/10/30 | SUPPL-36（补充） | Approval | Labeling | |||
| 1973/10/02 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | |||
| 1973/10/02 | SUPPL-40（补充） | Approval | Manufacturing (CMC) | |||
| 1973/07/02 | SUPPL-35（补充） | Approval | Labeling | |||
| 1973/03/16 | SUPPL-34（补充） | Approval | Labeling | |||
| 1972/09/18 | SUPPL-33（补充） | Approval | Manufacturing (CMC) | |||
| 1972/06/23 | SUPPL-32（补充） | Approval | Labeling | |||
| 1972/06/09 | SUPPL-31（补充） | Approval | Labeling | |||
| 1971/09/16 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | |||
| 1971/05/25 | SUPPL-29（补充） | Approval | Labeling | |||
| 1971/03/12 | SUPPL-28（补充） | Approval | Labeling | |||
| 1971/02/22 | SUPPL-27（补充） | Approval | Manufacturing (CMC) | |||
| 1971/02/08 | SUPPL-26（补充） | Approval | Labeling | |||
| 1970/10/14 | SUPPL-24（补充） | Approval | Manufacturing (CMC) | |||
| 1970/10/09 | SUPPL-25（补充） | Approval | Manufacturing (CMC) | |||
| 1970/04/01 | SUPPL-23（补充） | Approval | Manufacturing (CMC) | |||
| 1970/03/12 | SUPPL-22（补充） | Approval | Manufacturing (CMC) | |||
| 1970/03/12 | SUPPL-21（补充） | Approval | Manufacturing (CMC) | |||
| 1969/11/19 | SUPPL-20（补充） | Approval | Labeling | |||
| 1969/11/07 | SUPPL-19（补充） | Approval | Manufacturing (CMC) | |||
| 1969/09/09 | SUPPL-17（补充） | Approval | Manufacturing (CMC) | |||
| 1969/09/08 | SUPPL-18（补充） | Approval | Manufacturing (CMC) | |||
| 1969/07/31 | SUPPL-16（补充） | Approval | Labeling | |||
| 1969/06/12 | SUPPL-15（补充） | Approval | Manufacturing (CMC) | |||
| 1969/02/11 | SUPPL-14（补充） | Approval | Manufacturing (CMC) | |||
| 1969/02/11 | SUPPL-13（补充） | Approval | Labeling | |||
| 1968/12/30 | SUPPL-12（补充） | Approval | Labeling | |||
| 1968/12/18 | SUPPL-11（补充） | Approval | Manufacturing (CMC) | |||
| 1968/06/19 | SUPPL-9（补充） | Approval | Manufacturing (CMC) | |||
| 1968/06/13 | SUPPL-10（补充） | Approval | Labeling | |||
| 1968/04/08 | SUPPL-8（补充） | Approval | Manufacturing (CMC) | |||
| 1968/02/05 | SUPPL-6（补充） | Approval | Manufacturing (CMC) | |||
| 1967/12/06 | ORIG-1（原始申请） | Approval | UNKNOWN |
