药品注册申请号:065356
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 TABLET;ORAL EQ 50MG BASE No No AB 2006/05/31 2006/05/31 Prescription
002 DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 75MG BASE No No AB 2006/05/31 Prescription
003 DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 100MG BASE No No AB 2006/05/31 Prescription
004 DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 150MG BASE No No AB 2010/07/29 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
2022/06/22 SUPPL-15(补充) Approval Labeling STANDARD
2022/06/22 SUPPL-13(补充) Approval Labeling STANDARD
2022/06/22 SUPPL-11(补充) Approval Labeling STANDARD
2015/01/16 SUPPL-10(补充) Approval Labeling STANDARD
2010/12/13 SUPPL-8(补充) Approval Labeling
2010/07/29 SUPPL-3(补充) Approval Labeling
2006/05/31 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:DOXYCYCLINE 剂型/给药途径:TABLET;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
065070 001 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2000/12/15 STRIDES PHARMA
065285 001 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2005/12/08 LANNETT CO INC
065356 001 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2006/05/31 SUN PHARM INDS LTD
091605 001 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2011/12/20 HERITAGE
209582 001 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2017/09/28 ZYDUS PHARMS
活性成分:DOXYCYCLINE 剂型/给药途径:TABLET;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
065070 003 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2002/12/30 STRIDES PHARMA
065356 002 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2006/05/31 SUN PHARM INDS LTD
065285 003 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2008/07/30 LANNETT CO INC
091605 002 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2011/12/20 HERITAGE
209582 002 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 75MG BASE Prescription No No AB 2017/09/28 ZYDUS PHARMS
活性成分:DOXYCYCLINE 剂型/给药途径:TABLET;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
065070 002 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2000/12/15 STRIDES PHARMA
065285 002 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2005/12/08 LANNETT CO INC
065356 003 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2006/05/31 SUN PHARM INDS LTD
091605 003 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2011/12/20 HERITAGE
209582 003 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2017/09/28 ZYDUS PHARMS
活性成分:DOXYCYCLINE 剂型/给药途径:TABLET;ORAL 规格:EQ 150MG 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
065070 004 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 150MG BASE Prescription No No AB 2005/07/14 STRIDES PHARMA
065285 004 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 150MG BASE Prescription No No AB 2008/07/30 LANNETT CO INC
065356 004 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 150MG BASE Prescription No No AB 2010/07/29 SUN PHARM INDS LTD
091605 004 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 150MG BASE Prescription No Yes AB 2011/12/20 HERITAGE
209582 004 ANDA DOXYCYCLINE DOXYCYCLINE TABLET;ORAL EQ 150MG BASE Prescription No No AB 2017/09/28 ZYDUS PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database