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 |
|---|
| 2006/08/31 |
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:GLYCOPYRROLATE 剂型/给药途径:TABLET;ORAL 规格:1MG 治疗等效代码:AA
| 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 |
|---|
| 012827 |
001 |
NDA |
ROBINUL |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
Yes |
No |
AA |
Approved Prior to Jan 1, 1982
|
CASPER PHARMA LLC |
| 040653 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
No |
Yes |
AA |
2006/08/31
|
PAR PHARM |
| 040847 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2008/03/21
|
DR REDDYS LABS LTD |
| 040821 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2008/12/29
|
RISING |
| 040844 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2009/08/18
|
SUN PHARM INDS LTD |
| 090020 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2011/10/19
|
OXFORD PHARMS |
| 090195 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2012/09/21
|
LEADING |
| 202675 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2013/04/15
|
AUROBINDO PHARMA |
| 091182 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2014/02/03
|
INDOCO |
| 091413 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2016/06/20
|
NATCO |
| 207201 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2017/01/03
|
HERITAGE PHARMS INC |
| 203657 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2018/11/30
|
ALEMBIC |
活性成分:GLYCOPYRROLATE 剂型/给药途径:TABLET;ORAL 规格:2MG 治疗等效代码:AA
| 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 |
|---|
| 012827 |
002 |
NDA |
ROBINUL FORTE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
Yes |
No |
AA |
Approved Prior to Jan 1, 1982
|
CASPER PHARMA LLC |
| 040653 |
002 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
No |
Yes |
AA |
2006/08/31
|
PAR PHARM |
| 040847 |
002 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AA |
2008/03/21
|
DR REDDYS LABS LTD |
| 040821 |
002 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AA |
2008/12/29
|
RISING |
| 040844 |
002 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AA |
2009/08/18
|
SUN PHARM INDS LTD |
| 090020 |
002 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AA |
2011/10/19
|
OXFORD PHARMS |
| 090195 |
002 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AA |
2012/09/21
|
LEADING |
| 091182 |
002 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AA |
2014/02/03
|
INDOCO |
| 091413 |
002 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AA |
2016/06/20
|
NATCO |
| 207201 |
002 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AA |
2017/01/03
|
HERITAGE PHARMS INC |
| 202675 |
002 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AA |
2018/10/30
|
AUROBINDO PHARMA |
| 203657 |
002 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AA |
2018/11/30
|
ALEMBIC |