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 |
|---|
| 2022/03/31 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/01/30 |
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:FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 剂型/给药途径:POWDER;INHALATION 规格:0.1MG/INH;EQ 0.05MG BASE/INH 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 |
|---|
| 021077 |
001 |
NDA |
ADVAIR DISKUS 100/50 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.1MG/INH;EQ 0.05MG BASE/INH |
Prescription |
Yes |
Yes |
AB |
2000/08/24
|
GLAXO GRP LTD |
| 208891 |
001 |
ANDA |
WIXELA INHUB |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.1MG/INH;EQ 0.05MG BASE/INH |
Prescription |
No |
No |
AB |
2019/01/30
|
MYLAN |
| 203433 |
001 |
ANDA |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.1MG/INH;EQ 0.05MG BASE/INH |
Prescription |
No |
No |
AB |
2020/12/17
|
HIKMA |
| 213948 |
001 |
ANDA |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.1MG/INH;EQ 0.05MG BASE/INH |
Prescription |
No |
No |
AB |
2021/12/13
|
TEVA PHARMS USA |
活性成分:FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 剂型/给药途径:POWDER;INHALATION 规格:0.25MG/INH;EQ 0.05MG BASE/INH 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 |
|---|
| 021077 |
002 |
NDA |
ADVAIR DISKUS 250/50 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.25MG/INH;EQ 0.05MG BASE/INH |
Prescription |
Yes |
Yes |
AB |
2000/08/24
|
GLAXO GRP LTD |
| 208891 |
002 |
ANDA |
WIXELA INHUB |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.25MG/INH;EQ 0.05MG BASE/INH |
Prescription |
No |
No |
AB |
2019/01/30
|
MYLAN |
| 203433 |
002 |
ANDA |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.25MG/INH;EQ 0.05MG BASE/INH |
Prescription |
No |
No |
AB |
2020/12/17
|
HIKMA |
| 213948 |
002 |
ANDA |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.25MG/INH;EQ 0.05MG BASE/INH |
Prescription |
No |
No |
AB |
2021/12/13
|
TEVA PHARMS USA |
活性成分:FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 剂型/给药途径:POWDER;INHALATION 规格:0.5MG/INH;EQ 0.05MG BASE/INH 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 |
|---|
| 021077 |
003 |
NDA |
ADVAIR DISKUS 500/50 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.5MG/INH;EQ 0.05MG BASE/INH |
Prescription |
Yes |
Yes |
AB |
2000/08/24
|
GLAXO GRP LTD |
| 208891 |
003 |
ANDA |
WIXELA INHUB |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.5MG/INH;EQ 0.05MG BASE/INH |
Prescription |
No |
No |
AB |
2019/01/30
|
MYLAN |
| 213948 |
003 |
ANDA |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.5MG/INH;EQ 0.05MG BASE/INH |
Prescription |
No |
No |
AB |
2021/12/13
|
TEVA PHARMS USA |
| 203433 |
003 |
ANDA |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
POWDER;INHALATION |
0.5MG/INH;EQ 0.05MG BASE/INH |
Prescription |
No |
No |
AB |
2023/12/19
|
HIKMA |
