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 |
|---|
| 2019/09/04 |
SUPPL-23（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2006/09/26 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 1997/06/23 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/02/28 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/05/09 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/05/09 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/05/09 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/03/04 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/03/15 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 1990/01/25 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1988/09/08 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1986/07/23 |
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:INJECTABLE;INJECTION 规格:0.2MG/ML 治疗等效代码:AP
| 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 |
|---|
| 089335 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
1986/07/23
|
AM REGENT |
| 090963 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
Yes |
AP |
2011/09/21
|
HIKMA FARMACEUTICA |
| 208973 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2017/06/15
|
AMNEAL |
| 207639 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2017/06/23
|
SOMERSET THERAPS LLC |
| 209328 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2017/10/27
|
FRESENIUS KABI USA |
| 210842 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2018/10/25
|
PIRAMAL CRITICAL |
| 210927 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2018/10/31
|
PRINSTON INC |
| 209024 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2018/10/31
|
FRESENIUS KABI USA |
| 210244 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Discontinued |
No |
No |
AP |
2018/11/28
|
EUGIA PHARMA |
| 211705 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2019/03/20
|
CAPLIN |
| 211334 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2019/05/14
|
SANDOZ |
| 212612 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2019/09/30
|
GLAND PHARMA LTD |
| 210246 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2019/10/29
|
APOTEX |
| 210083 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2020/02/21
|
SAGENT |
| 213238 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2020/07/08
|
ACCORD HLTHCARE |
| 212227 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2021/03/04
|
XIROMED |
| 212802 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2021/07/06
|
MEITHEAL |
| 212591 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2021/10/13
|
UMEDICA |
| 215333 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2022/10/21
|
AMNEAL |
| 214635 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2022/10/26
|
ALEMBIC |
| 212871 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2022/11/29
|
OMNIVIUM PHARMS |
| 213655 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Discontinued |
No |
No |
AP |
2023/02/07
|
LUPIN LTD |
| 217354 |
001 |
ANDA |
GLYCOPYRROLATE |
GLYCOPYRROLATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Discontinued |
No |
No |
AP |
2023/02/27
|
MANKIND PHARMA |