药品注册申请号:065053
申请类型:ANDA (仿制药申请)
申请人:SUN PHARM INDS LTD
申请人全名:SUN PHARMACEUTICAL INDUSTRIES 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 DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE No No AB 2000/11/22 2000/11/22 Prescription
002 DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE No Yes AB 2000/11/22 Prescription
003 DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE No No AB 2003/09/10 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2014/09/21 SUPPL 18 Approval Labeling STANDARD
2012/12/14 SUPPL 17 Approval Labeling STANDARD
2011/11/30 SUPPL 15 Approval Labeling
2009/04/14 SUPPL 14 Approval Labeling
2005/05/20 SUPPL 9 Approval Labeling
2004/08/17 SUPPL 7 Approval Labeling
2003/09/10 SUPPL 5 Approval Labeling
2003/09/10 SUPPL 4 Approval Manufacturing (CMC)
2003/04/30 SUPPL 6 Approval Labeling
2002/12/23 SUPPL 3 Approval Labeling
2001/12/13 SUPPL 2 Approval Manufacturing (CMC)
2001/12/13 SUPPL 1 Approval Manufacturing (CMC)
2000/11/22 ORIG 1 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:DOXYCYCLINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 50MG BASE 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
065053 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2000/11/22 SUN PHARM INDS LTD
065055 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2000/12/01 PAR PHARM
204234 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2014/03/05 LUPIN LTD
204446 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2015/05/28 COSETTE
205115 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2016/02/18 ZYDUS PHARMS
209396 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2017/09/29 MAYNE PHARMA INC
活性成分:DOXYCYCLINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 100MG BASE 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
065053 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No Yes AB 2000/11/22 SUN PHARM INDS LTD
065055 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2000/12/01 PAR PHARM
204234 003 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2014/03/05 LUPIN LTD
204446 003 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2015/05/28 COSETTE
205115 003 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2016/02/18 ZYDUS PHARMS
209165 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2017/07/28 ALEMBIC PHARMS LTD
209396 003 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2017/09/29 MAYNE PHARMA INC
活性成分:DOXYCYCLINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 75MG BASE 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
065053 003 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2003/09/10 SUN PHARM INDS LTD
204234 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2014/03/05 LUPIN LTD
204446 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2015/05/28 COSETTE
205115 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2016/02/18 ZYDUS PHARMS
209165 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2017/07/28 ALEMBIC PHARMS LTD
209396 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2017/09/29 MAYNE PHARMA INC
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2020 DrugFuture->U.S. FDA Drugs Database