药品注册申请号：213761
申请类型：ANDA (仿制药申请)
申请人：QUAGEN
申请人全名：QUAGEN PHARMACEUTICALS 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 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML No No AA 2021/06/02 2021/06/02 Prescription
002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML No No AA 2021/06/02 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
2021/06/02 ORIG-1（原始申请） Approval 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
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:OXYCODONE HYDROCHLORIDE 剂型/给药途径:SOLUTION;ORAL 规格:5MG/5ML 治疗等效代码:AA
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
201194 001 NDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Discontinued Yes No AA 2012/01/12 VISTAPHARM LLC
204037 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No Yes AA 2013/07/15 HIKMA
200535 002 NDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription Yes No AA 2013/08/22 GENUS LIFESCIENCES
204979 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2015/06/01 ANI PHARMS
207511 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2016/11/23 WES PHARMA INC
208593 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2017/07/21 ABHAI LLC
208817 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Discontinued No No AA 2017/08/10 HIKMA
209021 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2017/11/09 ASCENT PHARMS INC
210758 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2018/04/30 SPECGX LLC
206914 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2019/02/01 PHARM ASSOC
211748 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2019/02/07 ALKEM LABS LTD
213761 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2021/06/02 QUAGEN
活性成分:OXYCODONE HYDROCHLORIDE 剂型/给药途径:SOLUTION;ORAL 规格:100MG/5ML 治疗等效代码:AA
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
200535 001 NDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML Prescription Yes Yes AA 2010/10/20 GENUS LIFESCIENCES
202537 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML Discontinued No No AA 2012/07/30 VISTAPHARM
204092 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML Discontinued No No AA 2014/06/05 DR REDDYS LABS SA
208593 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML Prescription No No AA 2017/07/21 ABHAI LLC
208795 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML Discontinued No No AA 2017/08/07 HIKMA
206822 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML Prescription No No AA 2017/08/15 PHARM ASSOC
209897 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML Prescription No No AA 2017/09/06 WES PHARMA INC
209021 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML Prescription No No AA 2017/11/09 ASCENT PHARMS INC
210758 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML Prescription No No AA 2018/04/30 SPECGX LLC
211749 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML Prescription No No AA 2019/02/04 ALKEM LABS LTD
213761 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 100MG/5ML Prescription No No AA 2021/06/02 QUAGEN
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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