药品注册申请号:202547
申请类型:ANDA (仿制药申请)
申请人:ORBION PHARMS
申请人全名:ORBION PHARMACEUTICALS PRIVATE LTD
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 ARIPIPRAZOLE ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 10MG No No AB 2017/12/11 2017/12/11 Prescription
002 ARIPIPRAZOLE ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 15MG No No AB 2017/12/11 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
2021/02/01 SUPPL-3(补充) Approval Labeling STANDARD
2020/02/05 SUPPL-2(补充) Approval Labeling STANDARD
2020/02/05 SUPPL-1(补充) Approval Labeling STANDARD
2017/12/11 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
与本品治疗等效的药品
活性成分:ARIPIPRAZOLE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:10MG 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
202102 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No Yes AB 2015/04/28 ALEMBIC
202547 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2017/12/11 ORBION PHARMS
207240 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2018/04/18 SCIEGEN PHARMS INC
090165 001 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 10MG Prescription No No AB 2018/08/28 SQUARE PHARMS
活性成分:ARIPIPRAZOLE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:15MG 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
202102 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2015/04/28 ALEMBIC
202547 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2017/12/11 ORBION PHARMS
207240 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2018/04/18 SCIEGEN PHARMS INC
090165 002 ANDA ARIPIPRAZOLE ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Prescription No No AB 2018/08/28 SQUARE PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
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