药品注册申请号：074802
申请类型：ANDA (仿制药申请)
申请人：HOSPIRA
申请人全名：HOSPIRA INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTABLE;INJECTION 15MG/ML No Yes AP 1997/06/05 1997/06/05 Prescription
002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTABLE;INJECTION 30MG/ML No Yes AP 1997/06/05 Prescription
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
2024/03/04 SUPPL-56（补充） Approval Labeling STANDARD
2022/11/15 SUPPL-52（补充） Approval Labeling STANDARD
2021/04/28 SUPPL-48（补充） Approval Labeling STANDARD
2016/05/09 SUPPL-40（补充） Approval Labeling STANDARD
2014/12/14 SUPPL-38（补充） Approval Labeling STANDARD
2013/05/29 SUPPL-37（补充） Approval Labeling STANDARD
2003/03/14 SUPPL-22（补充） Approval Labeling
2002/12/16 SUPPL-18（补充） Approval Manufacturing (CMC)
2002/10/25 SUPPL-20（补充） Approval Manufacturing (CMC)
2002/07/29 SUPPL-19（补充） Approval Manufacturing (CMC)
2002/02/04 SUPPL-16（补充） Approval Manufacturing (CMC)
2001/09/17 SUPPL-17（补充） Approval Manufacturing (CMC)
2001/03/22 SUPPL-13（补充） Approval Manufacturing (CMC)
2001/03/22 SUPPL-12（补充） Approval Manufacturing (CMC)
2001/03/06 SUPPL-14（补充） Approval Manufacturing (CMC)
2001/02/14 SUPPL-15（补充） Approval Manufacturing (CMC)
2000/09/25 SUPPL-11（补充） Approval Manufacturing (CMC)
2000/01/07 SUPPL-4（补充） Approval Labeling
2000/01/07 SUPPL-3（补充） Approval Manufacturing (CMC)
1999/12/10 SUPPL-9（补充） Approval Labeling
1999/12/10 SUPPL-8（补充） Approval Manufacturing (CMC)
1999/12/10 SUPPL-7（补充） Approval Manufacturing (CMC)
1999/12/10 SUPPL-6（补充） Approval Manufacturing (CMC)
1999/12/10 SUPPL-5（补充） Approval Manufacturing (CMC)
1999/09/23 SUPPL-10（补充） Approval Manufacturing (CMC)
1997/12/08 SUPPL-2（补充） Approval Labeling
1997/06/12 SUPPL-1（补充） Approval Labeling
1997/06/05 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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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RLDRSTE 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RLDRSTE 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
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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