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 |
|---|
| 2001/05/30 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/12/29 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/10/16 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/04/18 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/04/18 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/04/18 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/04/18 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/04/18 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/06/28 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/02/07 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/02/10 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/02/10 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/12/28 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/12/22 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/12/22 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1993/12/22 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/02/11 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/05/28 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:NYSTATIN; TRIAMCINOLONE ACETONIDE 剂型/给药途径:CREAM;TOPICAL 规格:100,000 UNITS/GM;0.1% 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 |
|---|
| 062367 |
001 |
ANDA |
MYKACET |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Discontinued |
No |
No |
AT |
1985/05/28
|
COSETTE |
| 062599 |
001 |
ANDA |
NYSTATIN AND TRIAMCINOLONE ACETONIDE |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Prescription |
No |
No |
AT |
1985/10/08
|
FOUGERA PHARMS INC |
| 062364 |
001 |
ANDA |
NYSTATIN AND TRIAMCINOLONE ACETONIDE |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Prescription |
No |
Yes |
AT |
1987/12/22
|
TARO |
| 208136 |
001 |
ANDA |
NYSTATIN AND TRIAMCINOLONE ACETONIDE |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Prescription |
No |
No |
AT |
2016/10/24
|
GLENMARK PHARMS LTD |
| 208326 |
001 |
ANDA |
NYSTATIN AND TRIAMCINOLONE ACETONIDE |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Prescription |
No |
No |
AT |
2016/10/26
|
DR REDDYS |
| 208479 |
001 |
ANDA |
NYSTATIN AND TRIAMCINOLONE ACETONIDE |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Prescription |
No |
No |
AT |
2017/08/14
|
PADAGIS ISRAEL |
| 207730 |
001 |
ANDA |
NYSTATIN AND TRIAMCINOLONE ACETONIDE |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Prescription |
No |
No |
AT |
2017/12/26
|
CROWN LABS INC |
| 209990 |
001 |
ANDA |
NYSTATIN AND TRIAMCINOLONE ACETONIDE |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Prescription |
No |
No |
AT |
2018/02/15
|
AMNEAL |
| 208205 |
001 |
ANDA |
NYSTATIN AND TRIAMCINOLONE ACETONIDE |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Prescription |
No |
No |
AT |
2018/05/31
|
LUPIN LTD |
| 213142 |
001 |
ANDA |
NYSTATIN AND TRIAMCINOLONE ACETONIDE |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Discontinued |
No |
No |
AT |
2020/07/14
|
TORRENT |
| 214090 |
001 |
ANDA |
NYSTATIN AND TRIAMCINOLONE ACETONIDE |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Prescription |
No |
No |
AT |
2021/03/31
|
ALEMBIC |
| 214181 |
001 |
ANDA |
NYSTATIN AND TRIAMCINOLONE ACETONIDE |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CREAM;TOPICAL |
100,000 UNITS/GM;0.1% |
Prescription |
No |
No |
AT |
2022/07/13
|
MACLEODS PHARMS LTD |