药品注册申请号：211935
申请类型：ANDA (仿制药申请)
申请人：ALEMBIC
申请人全名：ALEMBIC PHARMACEUTICALS 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 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG No No AB 2021/06/25 2021/06/25 Prescription
002 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG No No AB 2021/06/25 Prescription
003 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG No No AB 2021/06/25 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
2021/06/25 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
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:NITROFURANTOIN, MACROCRYSTALLINE 剂型/给药途径:CAPSULE;ORAL 规格:25MG 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
016620 003 NDA MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG Prescription Yes No AB Approved Prior to Jan 1, 1982 ALMATICA
091095 001 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG Discontinued No No AB 2015/06/18 ACTAVIS LABS FL INC
201722 001 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG Prescription No No AB 2016/02/16 SUN PHARM INDUSTRIES
211935 001 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG Prescription No No AB 2021/06/25 ALEMBIC
217272 001 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG Prescription No No AB 2023/03/21 MANKIND PHARMA
077025 002 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG Prescription No No AB 2024/10/02 AUROBINDO PHARMA USA
活性成分:NITROFURANTOIN, MACROCRYSTALLINE 剂型/给药途径:CAPSULE;ORAL 规格:50MG 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
016620 001 NDA MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG Prescription Yes No AB Approved Prior to Jan 1, 1982 ALMATICA
073671 001 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG Prescription No No AB 1993/01/28 IMPAX LABS INC
074967 001 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG Prescription No No AB 1997/07/09 AUROBINDO PHARMA USA
091095 002 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG Discontinued No No AB 2015/06/18 ACTAVIS LABS FL INC
201722 002 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG Prescription No No AB 2016/02/16 SUN PHARM INDUSTRIES
205005 001 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG Prescription No No AB 2017/12/12 ZYDUS PHARMS
203233 001 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG Prescription No No AB 2018/07/09 NOVEL LABS INC
211935 002 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG Prescription No No AB 2021/06/25 ALEMBIC
217272 002 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG Prescription No No AB 2023/03/21 MANKIND PHARMA
活性成分:NITROFURANTOIN, MACROCRYSTALLINE 剂型/给药途径:CAPSULE;ORAL 规格:100MG 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
016620 002 NDA MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 ALMATICA
073652 001 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG Prescription No No AB 1993/01/28 IMPAX LABS INC
074967 002 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG Prescription No No AB 1997/07/09 AUROBINDO PHARMA USA
077025 001 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG Prescription No No AB 2004/08/18 AUROBINDO PHARMA USA
091095 003 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG Discontinued No No AB 2015/06/18 ACTAVIS LABS FL INC
201722 003 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG Prescription No No AB 2016/02/16 SUN PHARM INDUSTRIES
205005 002 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG Prescription No No AB 2017/12/12 ZYDUS PHARMS
203233 002 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG Prescription No No AB 2018/07/09 NOVEL LABS INC
211935 003 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG Prescription No No AB 2021/06/25 ALEMBIC
217272 003 ANDA NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG Prescription No No AB 2023/03/21 MANKIND PHARMA
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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