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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2023/06/20 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2024/11/21 |
SUPPL-1（补充） |
Approval |
Labeling-Package Insert |
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: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
|
APOTEX |
| 078737 |
001 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
15MG/ML |
Discontinued |
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 |
Discontinued |
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 |
Discontinued |
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
|
APOTEX |
| 078737 |
002 |
ANDA |
KETOROLAC TROMETHAMINE |
KETOROLAC TROMETHAMINE |
INJECTABLE;INJECTION |
30MG/ML |
Discontinued |
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 |