药品注册申请号:018140
申请类型:NDA (新药申请)
申请人:HIKMA
申请人全名:HIKMA PHARMACEUTICALS USA 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 ATIVAN LORAZEPAM INJECTABLE;INJECTION 2MG/ML Yes Yes AP 1980/07/25 Approved Prior to Jan 1, 1982 Prescription
002 ATIVAN LORAZEPAM INJECTABLE;INJECTION 4MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 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
2023/01/13 SUPPL-51(补充) Approval Labeling STANDARD
2021/02/05 SUPPL-46(补充) Approval Labeling 901 REQUIRED
2017/04/27 SUPPL-42(补充) Approval Labeling 901 REQUIRED
2017/04/27 SUPPL-41(补充) Approval Labeling 901 REQUIRED
2016/05/27 SUPPL-40(补充) Approval Labeling STANDARD
2016/04/18 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
2015/10/02 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
2006/11/29 SUPPL-28(补充) Approval Labeling STANDARD
2001/12/12 SUPPL-27(补充) Approval Labeling STANDARD
2000/09/26 SUPPL-26(补充) Approval Labeling STANDARD
1998/10/16 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1997/11/04 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1997/09/05 SUPPL-3(补充) Approval Efficacy
1996/09/26 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1996/03/19 SUPPL-22(补充) Approval Labeling STANDARD
1996/03/19 SUPPL-12(补充) Approval Labeling
1996/03/19 SUPPL-11(补充) Approval Labeling
1996/03/19 SUPPL-9(补充) Approval Labeling
1995/03/08 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1995/01/06 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1993/09/29 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1993/09/29 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1993/06/03 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1992/08/18 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1991/06/26 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1991/01/02 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1989/11/03 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1989/06/13 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1987/04/24 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1987/04/13 SUPPL-8(补充) Approval Labeling
1984/02/14 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1984/02/14 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1983/06/14 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1981/02/02 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1980/09/09 SUPPL-1(补充) Approval Labeling
1980/07/25 ORIG-1(原始申请) Approval Type 3 - New Dosage Form 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
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
与本品治疗等效的药品
活性成分:LORAZEPAM 剂型/给药途径:INJECTABLE;INJECTION 规格:2MG/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
018140 001 NDA ATIVAN LORAZEPAM INJECTABLE;INJECTION 2MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HIKMA
074243 001 ANDA LORAZEPAM LORAZEPAM INJECTABLE;INJECTION 2MG/ML Prescription No No AP 1994/04/12 HOSPIRA
074282 001 ANDA LORAZEPAM LORAZEPAM INJECTABLE;INJECTION 2MG/ML Prescription No No AP 1994/05/27 HOSPIRA
075025 001 ANDA LORAZEPAM LORAZEPAM INJECTABLE;INJECTION 2MG/ML Prescription No No AP 1998/07/23 RISING
076150 001 ANDA LORAZEPAM LORAZEPAM INJECTABLE;INJECTION 2MG/ML Prescription No No AP 2004/11/15 INTL MEDICATION SYS
活性成分:LORAZEPAM 剂型/给药途径:INJECTABLE;INJECTION 规格:4MG/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
018140 002 NDA ATIVAN LORAZEPAM INJECTABLE;INJECTION 4MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HIKMA
074243 002 ANDA LORAZEPAM LORAZEPAM INJECTABLE;INJECTION 4MG/ML Prescription No No AP 1994/04/12 HOSPIRA
074282 002 ANDA LORAZEPAM LORAZEPAM INJECTABLE;INJECTION 4MG/ML Prescription No No AP 1994/05/27 HOSPIRA
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database