药品注册申请号:212759
申请类型:ANDA (仿制药申请)
申请人:TEVA PHARMS USA
申请人全名:TEVA PHARMACEUTICALS USA 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 PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG No No AB 2022/01/25 2022/01/25 Prescription
002 PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG No No AB 2022/01/25 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
2022/08/11 SUPPL-1(补充) Approval Labeling STANDARD
2022/01/25 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:PIRFENIDONE 剂型/给药途径:TABLET;ORAL 规格:267MG 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
208780 001 NDA ESBRIET PIRFENIDONE TABLET;ORAL 267MG Prescription Yes No AB 2017/01/11 GENENTECH INC
212730 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2022/01/25 ACCORD HLTHCARE
212759 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2022/01/25 TEVA PHARMS USA
212570 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2022/03/25 AMNEAL
212560 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2022/04/28 SANDOZ
212680 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2022/05/18 MICRO LABS
212708 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2022/05/20 ALEMBIC
212772 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2022/05/24 MSN
212722 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2022/07/19 LAURUS
212747 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2022/07/21 AIZANT
212078 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2022/08/01 SCIEGEN PHARMS INC
212674 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2022/09/21 HETERO LABS LTD V
212709 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Prescription No No AB 2023/05/31 APOTEX
212403 001 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 267MG Discontinued No No AB 2023/08/23 LUPIN LTD
活性成分:PIRFENIDONE 剂型/给药途径:TABLET;ORAL 规格:801MG 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
208780 003 NDA ESBRIET PIRFENIDONE TABLET;ORAL 801MG Prescription Yes Yes AB 2017/01/11 GENENTECH INC
212730 002 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2022/01/25 ACCORD HLTHCARE
212759 002 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2022/01/25 TEVA PHARMS USA
212570 002 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2022/03/25 AMNEAL
212560 002 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2022/04/28 SANDOZ
212680 002 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2022/05/18 MICRO LABS
212708 002 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2022/05/20 ALEMBIC
212772 002 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2022/05/24 MSN
212722 003 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2022/07/19 LAURUS
212747 003 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2022/07/21 AIZANT
212078 002 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2022/08/01 SCIEGEN PHARMS INC
212674 002 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2022/09/21 HETERO LABS LTD V
212709 002 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Prescription No No AB 2023/05/31 APOTEX
212403 002 ANDA PIRFENIDONE PIRFENIDONE TABLET;ORAL 801MG Discontinued No No AB 2023/08/23 LUPIN LTD
更多信息
药品NDC数据与药品包装、标签说明书
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