药品注册申请号:076560
申请类型:ANDA (仿制药申请)
申请人:NEXGEN PHARMA INC
申请人全名:NEXGEN PHARMA 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 BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG No No AB 2004/06/10 2004/06/10 Prescription
002 BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 300MG;50MG;40MG;30MG No No None 2012/07/19 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2018/09/18 SUPPL 8 Approval REMS
2016/03/25 SUPPL 6 Approval Labeling STANDARD
2012/07/19 SUPPL 4 Approval Labeling
2012/07/19 SUPPL 3 Approval Labeling
2011/10/21 SUPPL 5 Approval Labeling
2004/06/10 ORIG 1 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
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:ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 剂型/给药途径:CAPSULE;ORAL 规格:325MG;50MG;40MG;30MG 治疗等效代码:AB
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
020232 001 NDA FIORICET W/ CODEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG Prescription Yes Yes AB 1992/07/30 ACTAVIS LABS UT INC
075929 001 ANDA BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG Prescription No No AB 2002/04/22 VINTAGE PHARMS
076560 001 ANDA BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG Prescription No No AB 2004/06/10 NEXGEN PHARMA INC
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