药品注册申请号:077425
申请类型:ANDA (仿制药申请)
申请人:MEITHEAL
申请人全名:MEITHEAL PHARMACEUTICALS 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 ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 60MG/20ML (3MG/ML) No Yes AP 2013/08/29 2013/08/29 Prescription
002 ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 90MG/30ML (3MG/ML) No Yes AP 2013/08/29 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
2023/10/27 SUPPL-9(补充) Approval Labeling STANDARD
2015/05/18 SUPPL-4(补充) Approval Labeling STANDARD
2015/05/18 SUPPL-2(补充) Approval Labeling STANDARD
2013/08/29 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
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 PC 2014/03/22**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:ADENOSINE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:60MG/20ML (3MG/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
077425 001 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 60MG/20ML (3MG/ML) Prescription No Yes AP 2013/08/29 MEITHEAL
203883 001 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 60MG/20ML (3MG/ML) Discontinued No No AP 2014/03/24 HOSPIRA
090212 001 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 60MG/20ML (3MG/ML) Prescription No No AP 2014/03/28 MYLAN ASI
202313 001 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 60MG/20ML (3MG/ML) Prescription No No AP 2014/09/15 AVET LIFESCIENCES
090450 001 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 60MG/20ML (3MG/ML) Prescription No No AP 2014/10/02 RISING
205331 001 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 60MG/20ML (3MG/ML) Prescription No No AP 2017/11/02 EUGIA PHARMA
077897 001 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 60MG/20ML (3MG/ML) Prescription No No AP 2017/11/27 FRESENIUS KABI USA
活性成分:ADENOSINE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:90MG/30ML (3MG/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
077425 002 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 90MG/30ML (3MG/ML) Prescription No Yes AP 2013/08/29 MEITHEAL
203883 002 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 90MG/30ML (3MG/ML) Discontinued No No AP 2014/03/24 HOSPIRA
090212 002 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 90MG/30ML (3MG/ML) Prescription No No AP 2014/03/28 MYLAN ASI
202313 002 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 90MG/30ML (3MG/ML) Prescription No No AP 2014/09/15 AVET LIFESCIENCES
090450 002 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 90MG/30ML (3MG/ML) Prescription No No AP 2014/10/02 RISING
205331 002 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 90MG/30ML (3MG/ML) Prescription No No AP 2017/11/02 EUGIA PHARMA
077897 002 ANDA ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 90MG/30ML (3MG/ML) Prescription No No AP 2017/11/27 FRESENIUS KABI USA
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药品NDC数据与药品包装、标签说明书
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