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 |
|---|
| 2018/11/23 |
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:TRIAMCINOLONE ACETONIDE 剂型/给药途径:OINTMENT;TOPICAL 规格:0.025% 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 |
|---|
| 085691 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.025% |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
FOUGERA PHARMS |
| 087385 |
002 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.025% |
Prescription |
Yes |
Yes |
AT |
Approved Prior to Jan 1, 1982
|
PADAGIS US |
| 089795 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.025% |
Prescription |
No |
No |
AT |
1988/12/23
|
COSETTE |
| 209828 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.025% |
Prescription |
No |
No |
AT |
2018/11/23
|
MACLEODS PHARMS LTD |
活性成分:TRIAMCINOLONE ACETONIDE 剂型/给药途径:OINTMENT;TOPICAL 规格: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 |
|---|
| 085691 |
003 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.1% |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
FOUGERA PHARMS |
| 087385 |
003 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.1% |
Prescription |
Yes |
Yes |
AT |
Approved Prior to Jan 1, 1982
|
PADAGIS US |
| 089796 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.1% |
Prescription |
No |
No |
AT |
1988/12/23
|
COSETTE |
| 040037 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.1% |
Prescription |
No |
No |
AT |
1994/09/30
|
TARO |
| 205373 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.1% |
Prescription |
No |
No |
AT |
2016/05/13
|
ENCUBE |
| 208320 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.1% |
Prescription |
No |
No |
AT |
2017/08/22
|
GLENMARK SPECLT |
| 207365 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.1% |
Prescription |
No |
No |
AT |
2018/10/12
|
CHARTWELL RX |
| 209828 |
002 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.1% |
Prescription |
No |
No |
AT |
2018/11/23
|
MACLEODS PHARMS LTD |
活性成分:TRIAMCINOLONE ACETONIDE 剂型/给药途径:OINTMENT;TOPICAL 规格:0.5% 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 |
|---|
| 085691 |
002 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.5% |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
FOUGERA PHARMS |
| 087385 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.5% |
Prescription |
Yes |
Yes |
AT |
Approved Prior to Jan 1, 1982
|
PADAGIS US |
| 206379 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.5% |
Prescription |
No |
No |
AT |
2016/07/22
|
GLENMARK PHARMS LTD |
| 208590 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.5% |
Discontinued |
No |
No |
AT |
2017/03/03
|
PAI HOLDINGS PHARM |
| 208925 |
001 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.5% |
Discontinued |
No |
No |
AT |
2017/10/06
|
COSETTE |
| 209828 |
003 |
ANDA |
TRIAMCINOLONE ACETONIDE |
TRIAMCINOLONE ACETONIDE |
OINTMENT;TOPICAL |
0.5% |
Prescription |
No |
No |
AT |
2018/11/23
|
MACLEODS PHARMS LTD |