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 |
|---|
| 2018/02/23 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/05/18 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2016/02/08 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/11/06 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
| 2013/05/21 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/11/08 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2010/07/28 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
STANDARD
;Orphan
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
与本品治疗等效的药品
活性成分:GLYCOPYRROLATE 剂型/给药途径:SOLUTION;ORAL 规格:1MG/5ML 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 |
|---|
| 022571 |
001 |
NDA |
CUVPOSA |
GLYCOPYRROLATE |
SOLUTION;ORAL |
1MG/5ML |
Prescription |
Yes |
Yes |
AA |
2010/07/28
|
MERZ PHARMS |
| 204438 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
SOLUTION;ORAL |
1MG/5ML |
Prescription |
No |
No |
AA |
2021/08/09
|
ENDO OPERATIONS |
| 212467 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
SOLUTION;ORAL |
1MG/5ML |
Prescription |
No |
No |
AA |
2022/07/05
|
SUVEN PHARMS |
| 213698 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
SOLUTION;ORAL |
1MG/5ML |
Prescription |
No |
No |
AA |
2022/07/05
|
ANNORA PHARMA |
| 214735 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
SOLUTION;ORAL |
1MG/5ML |
Prescription |
No |
No |
AA |
2024/08/19
|
GRANULES |
| 216368 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
SOLUTION;ORAL |
1MG/5ML |
Prescription |
No |
No |
AA |
2024/08/28
|
CHARTWELL RX |
| 216297 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
SOLUTION;ORAL |
1MG/5ML |
Prescription |
No |
No |
AA |
2024/10/07
|
SAPTALIS PHARMS |
