药品注册申请号:209315
申请类型:ANDA (仿制药申请)
申请人:INGENUS PHARMS LLC
申请人全名:INGENUS 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 ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML No No AP 2018/11/15 2018/11/15 Prescription
002 ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE;INJECTION 2MG/ML No No None 2021/01/14 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
2021/11/12 SUPPL-5(补充) Approval Labeling STANDARD
2020/05/15 SUPPL-2(补充) Approval Labeling STANDARD
2018/11/15 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
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:ARSENIC TRIOXIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1MG/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
208231 001 ANDA ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML Prescription No Yes AP 2018/08/31 FRESENIUS KABI USA
210802 001 ANDA ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2018/11/13 AMRING PHARMS
206228 001 ANDA ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2018/11/13 ZYDUS PHARMS
209315 001 ANDA ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2018/11/15 INGENUS PHARMS LLC
209780 001 ANDA ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2018/11/15 NEXUS
209873 001 ANDA ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2019/05/06 PENN LIFE
210739 001 ANDA ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2021/01/25 AMNEAL
215059 002 ANDA ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2022/04/22 GLAND PHARMA LTD
217413 001 ANDA ARSENIC TRIOXIDE ARSENIC TRIOXIDE INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2023/04/20 ORBICULAR
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