药品注册申请号:020793
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 CAFCIT CAFFEINE CITRATE SOLUTION;INTRAVENOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Yes Yes AP 1999/09/21 1999/09/21 Prescription
002 CAFCIT CAFFEINE CITRATE SOLUTION;ORAL EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2000/04/12 Discontinued
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
2020/03/02 SUPPL-19(补充) Approval Labeling STANDARD
2014/12/23 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
2010/06/11 SUPPL-9(补充) Approval Labeling UNKNOWN
2002/03/08 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
2002/02/08 SUPPL-4(补充) Approval Labeling STANDARD
2002/01/18 SUPPL-3(补充) Approval Labeling STANDARD
2000/04/14 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
2000/04/12 SUPPL-1(补充) Approval Efficacy STANDARD ;Orphan
1999/09/21 ORIG-1(原始申请) Approval Type 2 - New Active Ingredient PRIORITY ;Orphan
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
001 ODE 2006/09/21**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:CAFFEINE CITRATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:EQ 30MG BASE/3ML (EQ 10MG 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
020793 001 NDA CAFCIT CAFFEINE CITRATE SOLUTION;INTRAVENOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription Yes Yes AP 1999/09/21 HIKMA
077233 001 ANDA CAFFEINE CITRATE CAFFEINE CITRATE SOLUTION;INTRAVENOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2006/09/21 EXELA PHARMA SCIENCE
077906 001 ANDA CAFFEINE CITRATE CAFFEINE CITRATE SOLUTION;INTRAVENOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2007/05/15 AM REGENT
077997 001 ANDA CAFFEINE CITRATE CAFFEINE CITRATE SOLUTION;INTRAVENOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2007/07/20 FRESENIUS KABI USA
090827 001 ANDA CAFFEINE CITRATE CAFFEINE CITRATE SOLUTION;INTRAVENOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2012/08/29 SAGENT PHARMS
205013 001 ANDA CAFFEINE CITRATE CAFFEINE CITRATE SOLUTION;INTRAVENOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2015/09/22 EUGIA PHARMA
207400 001 ANDA CAFFEINE CITRATE CAFFEINE CITRATE SOLUTION;INTRAVENOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Prescription No No AP 2017/12/14 MICRO LABS
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