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 |
|---|
| 2015/06/19 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/06/09 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/12/11 |
SUPPL-19（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/10/15 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/04/03 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/05/11 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1995/08/29 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1995/08/29 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1992/05/08 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/09/03 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/09/21 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 1986/09/08 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1985/05/21 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1983/08/30 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1981/12/29 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 1981/03/10 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 1980/03/20 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1979/01/09 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
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:CARBOPROST TROMETHAMINE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 0.25MG BASE/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 |
|---|
| 017989 |
001 |
NDA |
HEMABATE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
PFIZER |
| 211941 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2019/07/02
|
DR REDDYS |
| 213118 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2021/03/25
|
SUNNY |
| 215337 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2022/01/27
|
AMNEAL |
| 214499 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2022/08/09
|
LONG GROVE PHARMS |
| 216882 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2023/02/13
|
CAPLIN |
| 216824 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2023/05/19
|
SOLA PHARMS |
| 216939 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2023/05/25
|
EUGIA PHARMA |
| 217198 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2023/06/15
|
ALEMBIC |
| 216897 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2023/07/25
|
STERISCIENCE |
| 217657 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2023/08/07
|
GLAND PHARMA LTD |
| 215901 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2024/01/25
|
ANI PHARMS |
| 218013 |
001 |
ANDA |
CARBOPROST TROMETHAMINE |
CARBOPROST TROMETHAMINE |
INJECTABLE;INJECTION |
EQ 0.25MG BASE/ML |
Prescription |
No |
No |
AP |
2024/04/03
|
MICRO LABS |
