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 |
2023/07/10 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/07/10 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/04/28 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/11/01 |
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:KETOROLAC TROMETHAMINE 剂型/给药途径:INJECTABLE;INJECTION 规格:15MG/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 |
074802 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
Yes |
AP |
1997/06/05
|
HOSPIRA |
075784 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
No |
AP |
2002/01/11
|
FRESENIUS KABI USA |
075772 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
No |
AP |
2004/07/21
|
HIKMA |
077942 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
No |
AP |
2007/03/27
|
WOCKHARDT |
078737 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
No |
AP |
2008/10/06
|
SUN PHARM |
091065 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
No |
AP |
2013/11/27
|
SAGENT PHARMS INC |
203242 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
No |
AP |
2015/10/07
|
FRESENIUS KABI USA |
204216 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
No |
AP |
2016/11/01
|
GLAND |
209900 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
No |
AP |
2018/07/25
|
BAXTER HLTHCARE CORP |
214456 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
No |
AP |
2022/11/02
|
ALEMBIC |
217789 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
No |
AP |
2023/05/10
|
CAPLIN |
217166 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Prescription |
No |
No |
AP |
2023/06/20
|
ASPIRO |
活性成分:KETOROLAC TROMETHAMINE 剂型/给药途径:INJECTABLE;INJECTION 规格:30MG/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 |
074802 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
Yes |
AP |
1997/06/05
|
HOSPIRA |
074993 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
1999/01/27
|
HOSPIRA |
075784 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2002/01/11
|
FRESENIUS KABI USA |
075772 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2004/07/21
|
HIKMA |
076271 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2004/10/06
|
SANDOZ |
077942 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2007/03/27
|
WOCKHARDT |
078737 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2008/10/06
|
SUN PHARM |
091065 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2013/11/27
|
SAGENT PHARMS INC |
203242 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2015/10/07
|
FRESENIUS KABI USA |
204216 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2016/11/01
|
GLAND |
209900 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2017/09/15
|
BAXTER HLTHCARE CORP |
211445 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2020/08/20
|
NEPHRON |
214456 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2022/11/02
|
ALEMBIC |
217789 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2023/05/10
|
CAPLIN |
217166 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Prescription |
No |
No |
AP |
2023/06/20
|
ASPIRO |