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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1970/07/29 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2021/10/14 |
SUPPL-63（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
STANDARD
|
|
|
| 2015/11/04 |
SUPPL-59（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/08/18 |
SUPPL-58（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/05/06 |
SUPPL-57（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/12/12 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/07/02 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2006/05/10 |
SUPPL-51（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
N/A
|
|
|
| 2005/10/13 |
SUPPL-49（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2004/06/24 |
SUPPL-47（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2004/04/27 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2002/11/27 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2001/08/30 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2001/07/03 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2001/07/03 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2001/02/12 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/07/07 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/07/07 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/06/20 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2000/04/05 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/11/02 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1997/02/18 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1995/03/21 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 1993/08/05 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1993/03/04 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1988/11/30 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/03/26 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 1986/11/14 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/06/10 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1985/03/14 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1984/08/13 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1984/05/04 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/08/12 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/08/12 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/03/14 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1982/05/14 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1982/03/10 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 1979/12/18 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1979/10/23 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1978/11/21 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/14 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1977/12/14 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/06/30 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/05/07 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1975/05/07 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1974/09/19 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC)-Control |
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:FLUOROURACIL; 剂型/给药途径:SOLUTION;TOPICAL; 规格:2%; 治疗等效代码:AT<<<
| 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 |
|---|
| 016831 |
001 |
NDA |
EFUDEX |
FLUOROURACIL |
SOLUTION;TOPICAL |
2% |
Prescription |
Yes |
Yes |
AT |
Approved Prior to Jan 1, 1982
|
EXTROVIS |
| 076526 |
001 |
ANDA |
FLUOROURACIL |
FLUOROURACIL |
SOLUTION;TOPICAL |
2% |
Prescription |
No |
No |
AT |
2003/11/05
|
TARO |
>>>活性成分:FLUOROURACIL; 剂型/给药途径:CREAM;TOPICAL; 规格:5%; 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 |
|---|
| 016831 |
003 |
NDA |
EFUDEX |
FLUOROURACIL |
CREAM;TOPICAL |
5% |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
EXTROVIS |
| 077524 |
001 |
ANDA |
FLUOROURACIL |
FLUOROURACIL |
CREAM;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2008/04/11
|
DR REDDYS LABS SA |
| 090368 |
001 |
ANDA |
FLUOROURACIL |
FLUOROURACIL |
CREAM;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2010/03/05
|
TARO |
| 214845 |
001 |
ANDA |
FLUOROURACIL |
FLUOROURACIL |
CREAM;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2021/10/07
|
ACCORD HLTHCARE |
| 216942 |
001 |
ANDA |
FLUOROURACIL |
FLUOROURACIL |
CREAM;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2025/02/12
|
ENCUBE |
