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 |
|---|
| 2023/01/09 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/04/17 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 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 |
与本品治疗等效的药品
活性成分:FLUCYTOSINE 剂型/给药途径:CAPSULE;ORAL 规格:250MG 治疗等效代码:AB
| 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 |
Discontinued |
No |
No |
AB |
2017/10/17
|
HIKMA |
| 212632 |
001 |
ANDA |
FLUCYTOSINE |
FLUCYTOSINE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2020/04/17
|
STRIDES PHARMA |
| 213665 |
001 |
ANDA |
FLUCYTOSINE |
FLUCYTOSINE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2020/05/01
|
AUROBINDO PHARMA LTD |
活性成分:FLUCYTOSINE 剂型/给药途径:CAPSULE;ORAL 规格:500MG 治疗等效代码:AB
| 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 |
Discontinued |
No |
No |
AB |
2017/10/17
|
HIKMA |
| 212632 |
002 |
ANDA |
FLUCYTOSINE |
FLUCYTOSINE |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2020/04/17
|
STRIDES PHARMA |
| 213665 |
002 |
ANDA |
FLUCYTOSINE |
FLUCYTOSINE |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2020/05/01
|
AUROBINDO PHARMA LTD |