药品注册申请号:073671
申请类型:ANDA (仿制药申请)
申请人:IMPAX LABS INC
申请人全名:IMPAX LABORATORIES 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 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG No No AB 1993/01/28 1993/01/28 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
2015/04/17 SUPPL-33(补充) Approval Labeling STANDARD
2015/04/17 SUPPL-25(补充) Approval Labeling
2011/10/12 SUPPL-32(补充) Approval Labeling
2009/04/15 SUPPL-29(补充) Approval Labeling
2008/01/16 SUPPL-28(补充) Approval Labeling
2008/01/16 SUPPL-27(补充) Approval Labeling
2007/07/13 SUPPL-22(补充) Approval Labeling
2002/07/29 SUPPL-11(补充) Approval Manufacturing (CMC)
2001/09/12 SUPPL-9(补充) Approval Manufacturing (CMC)
2000/08/02 SUPPL-8(补充) Approval Labeling
2000/08/02 SUPPL-7(补充) Approval Manufacturing (CMC)
2000/01/28 SUPPL-5(补充) Approval Manufacturing (CMC)
1999/11/29 SUPPL-6(补充) Approval Labeling
1999/09/14 SUPPL-4(补充) Approval Labeling
1998/02/13 SUPPL-3(补充) Approval Labeling
1997/05/12 SUPPL-2(补充) Approval Labeling
1993/05/21 SUPPL-1(补充) Approval Manufacturing (CMC)
1993/01/28 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: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
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