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 |
|---|
| 2017/08/31 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/08/31 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2017/08/31 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/08/31 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/10/01 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/10/01 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/09/17 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
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:LEVOCETIRIZINE DIHYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:5MG 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 |
|---|
| 090229 |
001 |
ANDA |
LEVOCETIRIZINE DIHYDROCHLORIDE |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2010/11/26
|
SYNTHON PHARMS |
| 090385 |
001 |
ANDA |
LEVOCETIRIZINE DIHYDROCHLORIDE |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
Yes |
AB |
2011/02/24
|
GLENMARK PHARMS LTD |
| 090392 |
001 |
ANDA |
LEVOCETIRIZINE DIHYDROCHLORIDE |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2011/02/24
|
DR REDDYS LABS LTD |
| 090199 |
001 |
ANDA |
LEVOCETIRIZINE DIHYDROCHLORIDE |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2011/08/22
|
TEVA PHARMS |
| 091264 |
001 |
ANDA |
LEVOCETIRIZINE DIHYDROCHLORIDE |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2012/06/29
|
HETERO LABS LTD III |
| 090362 |
001 |
ANDA |
LEVOCETIRIZINE DIHYDROCHLORIDE |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2013/01/31
|
SUN PHARM |
| 202046 |
001 |
ANDA |
LEVOCETIRIZINE DIHYDROCHLORIDE |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2013/09/17
|
MICRO LABS LTD INDIA |
| 203646 |
001 |
ANDA |
LEVOCETIRIZINE DIHYDROCHLORIDE |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2014/09/09
|
SCIEGEN PHARMS INC |
| 205564 |
001 |
ANDA |
LEVOCETIRIZINE DIHYDROCHLORIDE |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2016/01/11
|
MACLEODS PHARMS LTD |
| 204626 |
001 |
ANDA |
LEVOCETIRIZINE DIHYDROCHLORIDE |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2024/05/06
|
IPCA LABS LTD |