| 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 | ANCOBON | FLUCYTOSINE | CAPSULE;ORAL | 250MG | Yes | No | AB | 1971/11/26 | Approved Prior to Jan 1, 1982 | Prescription |
| 002 | ANCOBON | FLUCYTOSINE | CAPSULE;ORAL | 500MG | Yes | Yes | AB | Approved Prior to Jan 1, 1982 | Prescription |
| 批准日期 | 申请类型 | 申请提交号 | 审查批准结论 | 申请内容分类 | 审评分类（优先审评;罕用药状态） | 通知信、综述、标签、说明书 | 备注 |
|---|---|---|---|---|---|---|---|
| 2019/02/12 | SUPPL | 33 | Approval | Labeling | STANDARD | ||
| 2017/11/08 | SUPPL | 32 | Approval | Labeling | STANDARD | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | |
| 2016/02/05 | SUPPL | 31 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2014/01/08 | SUPPL | 30 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 2009/05/04 | SUPPL | 28 | Approval | Labeling | STANDARD | ||
| 2006/08/10 | SUPPL | 27 | Approval | Labeling | STANDARD | ||
| 2003/04/30 | SUPPL | 20 | Approval | Labeling | STANDARD | ||
| 2003/04/30 | SUPPL | 19 | Approval | Labeling | STANDARD | ||
| 2000/02/03 | SUPPL | 24 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1999/09/29 | SUPPL | 23 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1997/08/27 | SUPPL | 22 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1997/07/31 | SUPPL | 21 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1987/06/01 | SUPPL | 13 | Approval | Labeling | |||
| 1984/08/08 | SUPPL | 17 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1983/12/21 | SUPPL | 16 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1982/12/06 | SUPPL | 15 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1982/01/27 | SUPPL | 14 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1981/04/23 | SUPPL | 12 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1979/11/26 | SUPPL | 11 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1978/08/24 | SUPPL | 10 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1978/01/03 | SUPPL | 9 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1977/08/11 | SUPPL | 8 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1977/05/13 | SUPPL | 7 | Approval | Manufacturing (CMC) | PRIORITY | ||
| 1971/11/26 | ORIG | 1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|---|---|---|---|---|---|---|---|---|
| 无 | |||||||||
| 关联产品号 | 独占权代码 | 失效日期 | 备注 |
|---|---|---|---|
| 无 | |||
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 017001 | 001 | NDA | ANCOBON | FLUCYTOSINE | CAPSULE;ORAL | 250MG | Prescription | Yes | No | AB | Approved Prior to Jan 1, 1982 | BAUSCH |
| 201566 | 001 | ANDA | FLUCYTOSINE | FLUCYTOSINE | CAPSULE;ORAL | 250MG | Prescription | No | No | AB | 2011/06/28 | SIGMAPHARM LABS LLC |
| 204652 | 001 | ANDA | FLUCYTOSINE | FLUCYTOSINE | CAPSULE;ORAL | 250MG | Prescription | No | No | AB | 2017/07/07 | NOVEL LABS INC |
| 206550 | 001 | ANDA | FLUCYTOSINE | FLUCYTOSINE | CAPSULE;ORAL | 250MG | Prescription | No | No | AB | 2017/10/17 | HIKMA |
| 207536 | 001 | ANDA | FLUCYTOSINE | FLUCYTOSINE | CAPSULE;ORAL | 250MG | Prescription | No | No | AB | 2018/06/18 | RECIPHARM |
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 017001 | 002 | NDA | ANCOBON | FLUCYTOSINE | CAPSULE;ORAL | 500MG | Prescription | Yes | Yes | AB | Approved Prior to Jan 1, 1982 | BAUSCH |
| 201566 | 002 | ANDA | FLUCYTOSINE | FLUCYTOSINE | CAPSULE;ORAL | 500MG | Prescription | No | No | AB | 2011/06/28 | SIGMAPHARM LABS LLC |
| 204652 | 002 | ANDA | FLUCYTOSINE | FLUCYTOSINE | CAPSULE;ORAL | 500MG | Prescription | No | No | AB | 2017/07/07 | NOVEL LABS INC |
| 206550 | 002 | ANDA | FLUCYTOSINE | FLUCYTOSINE | CAPSULE;ORAL | 500MG | Prescription | No | No | AB | 2017/10/17 | HIKMA |
| 207536 | 002 | ANDA | FLUCYTOSINE | FLUCYTOSINE | CAPSULE;ORAL | 500MG | Prescription | No | No | AB | 2018/06/18 | RECIPHARM |
