药品注册申请号：075154
申请类型：ANDA (仿制药申请)
申请人：FRESENIUS KABI USA
申请人全名：FRESENIUS KABI USA LLC
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 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML No No AP 2000/06/20 2000/06/20 Prescription
002 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML No No AP 2000/06/20 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
2023/01/17 SUPPL-19（补充） Approval Labeling STANDARD
2017/08/14 SUPPL-13（补充） Approval Labeling STANDARD
2003/09/29 SUPPL-2（补充） Approval Labeling
2002/03/21 SUPPL-1（补充） Approval Labeling
2000/06/20 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:MIDAZOLAM HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 5MG 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RLDRSTE Code产品号批准日期申请人
075293 002 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No Yes AP 2000/06/20 HOSPIRA
075324 002 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2000/06/20 HIKMA
075421 001 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2000/06/20 HIKMA
075154 001 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2000/06/20 FRESENIUS KABI USA
075243 002 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2000/06/20 HIKMA
075247 001 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2000/06/23 HIKMA
075494 002 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2000/06/30 EPIC PHARMA LLC
075857 002 ANDA MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No Yes AP 2002/07/22 HOSPIRA
090315 002 ANDA MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2010/11/29 STERISCIENCE SPECLTS
090316 002 ANDA MIDOZALAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2011/05/04 STERISCIENCE SPECLTS
090850 001 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2012/01/25 GLAND PHARMA LTD
203460 002 ANDA MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2014/08/22 FRESENIUS KABI USA
212847 002 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2020/12/11 HIKMA
217504 002 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML Prescription No No AP 2023/08/21 MICRO LABS
活性成分:MIDAZOLAM HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1MG 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RLDRSTE Code产品号批准日期申请人
075293 001 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No Yes AP 2000/06/20 HOSPIRA
075324 001 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2000/06/20 HIKMA
075421 002 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2000/06/20 HIKMA
075154 002 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2000/06/20 FRESENIUS KABI USA
075243 001 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2000/06/20 HIKMA
075247 002 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2000/06/23 HIKMA
075494 001 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2000/06/30 EPIC PHARMA LLC
075857 001 ANDA MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No Yes AP 2002/07/22 HOSPIRA
090315 001 ANDA MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2010/11/29 STERISCIENCE SPECLTS
090316 001 ANDA MIDOZALAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2011/05/04 STERISCIENCE SPECLTS
090696 001 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2012/02/29 GLAND PHARMA LTD
203460 001 ANDA MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2014/08/22 FRESENIUS KABI USA
212847 001 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2020/12/11 HIKMA
217504 001 ANDA MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2023/08/21 MICRO LABS
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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