药品注册申请号：050795
申请类型：NDA (新药申请)
申请人：MAYNE PHARMA
申请人全名：MAYNE PHARMA INTERNATIONAL PTY 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 DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2005/05/06 2005/05/06 Discontinued
002 DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2005/05/06 Discontinued
003 DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2008/06/20 Discontinued
004 DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 80MG BASE Yes No AB 2013/04/11 Prescription
005 DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 200MG BASE Yes No AB 2013/04/11 Prescription
006 DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2014/12/19 Discontinued
007 DORYX MPC DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 60MG BASE Yes No AB 2016/05/20 Prescription
008 DORYX MPC DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2016/05/20 Discontinued
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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2005/05/06 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/03/31 SUPPL-37（补充） Approval Labeling-Package Insert STANDARD
2024/07/15 SUPPL-36（补充） Approval Manufacturing (CMC)-Packaging N/A
2022/07/25 SUPPL-30（补充） Approval Labeling-Package Insert STANDARD
2020/02/12 SUPPL-28（补充） Approval Labeling-Package Insert STANDARD
2018/02/07 SUPPL-26（补充） Approval Labeling-Package Insert STANDARD
2017/05/31 SUPPL-24（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2016/05/20 SUPPL-22（补充） Approval Efficacy-New Dosing Regimen STANDARD
2016/05/18 SUPPL-21（补充） Approval Labeling-Package Insert,Labeling-Package Insert,Labeling-Container/Carton Labels STANDARD
2015/06/04 SUPPL-18（补充） Approval Labeling-Package Insert STANDARD
2015/03/04 SUPPL-20（补充） Approval Labeling-Container/Carton Labels STANDARD
2014/12/19 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
2013/12/06 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
2013/12/06 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
2013/11/25 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
2013/04/11 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
2013/04/11 SUPPL-10（补充） Approval Efficacy-Labeling Change With Clinical Data PRIORITY
2011/09/13 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
2011/03/21 SUPPL-13（补充） Approval Labeling-Package Insert STANDARD
2008/06/20 SUPPL-5（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels N/A
2007/12/18 SUPPL-3（补充） Approval Labeling STANDARD
2006/12/19 SUPPL-2（补充） Approval Efficacy-Labeling Change With Clinical Data UNKNOWN
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
001 8715724 2028/02/03 Y 2014/05/07 PDF格式
002 8715724 2028/02/03 Y 2014/05/07 PDF格式
003 8715724 2028/02/03 Y 2014/05/07 PDF格式
004 8715724 2028/02/03 Y 2014/05/07 PDF格式
005 8715724 2028/02/03 Y 2014/05/07 PDF格式
006 8715724 2028/02/03 Y 2015/02/10 PDF格式
007 8715724 2028/02/03 Y 2016/05/23 PDF格式
9295652 2034/10/23 Y U-918 2016/05/23 PDF格式
9446057 2034/12/23 Y U-918 2016/09/09 PDF格式
9511031 2034/10/23 Y 2017/01/05 PDF格式
008 8715724 2028/02/03 Y 2016/05/23 PDF格式
9295652 2034/10/23 Y U-918 2016/05/23 PDF格式
9446057 2034/12/23 Y U-918 2016/09/09 PDF格式
9511031 2034/10/23 Y 2017/01/05 PDF格式
001 6958161 2022/12/15 Y U-918 PDF格式**本条是由Drugfuture回溯的历史信息**
002 6958161 2022/12/15 Y U-918 PDF格式**本条是由Drugfuture回溯的历史信息**
003 6958161 2022/12/15 Y U-918 PDF格式**本条是由Drugfuture回溯的历史信息**
004 6958161 2022/12/15 Y U-918 PDF格式**本条是由Drugfuture回溯的历史信息**
005 6958161 2022/12/15 Y U-918 PDF格式**本条是由Drugfuture回溯的历史信息**
006 6958161 2022/12/15 Y U-918 PDF格式**本条是由Drugfuture回溯的历史信息**
007 6958161 2022/12/15 Y U-918 PDF格式**本条是由Drugfuture回溯的历史信息**
008 6958161 2022/12/15 Y U-918 PDF格式**本条是由Drugfuture回溯的历史信息**
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
005 D-136 2016/04/11**本条是由Drugfuture回溯的历史信息**
NS 2016/04/11**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
>>>活性成分:DOXYCYCLINE HYCLATE; 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL; 规格:EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
050795 001 NDA DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2005/05/06 MAYNE PHARMA
>>>活性成分:DOXYCYCLINE HYCLATE; 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL; 规格:EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
050795 002 NDA DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2005/05/06 MAYNE PHARMA
>>>活性成分:DOXYCYCLINE HYCLATE; 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL; 规格:EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
050795 003 NDA DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2008/06/20 MAYNE PHARMA
>>>活性成分:DOXYCYCLINE HYCLATE; 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL; 规格:EQ 80MG 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
050795 004 NDA DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 80MG BASE Prescription Yes No AB 2013/04/11 MAYNE PHARMA
208741 004 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 80MG BASE Discontinued No No AB 2023/08/11 LUPIN
>>>活性成分:DOXYCYCLINE HYCLATE; 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL; 规格:EQ 200MG 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
050795 005 NDA DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 200MG BASE Prescription Yes No AB 2013/04/11 MAYNE PHARMA
207494 002 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2016/11/15 PRINSTON INC
090134 004 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2018/05/22 ACTAVIS ELIZABETH
200856 004 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 200MG BASE Prescription No Yes AB 2018/11/13 HERITAGE
213075 004 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 200MG BASE Prescription No No AB 2022/01/03 ALEMBIC
208741 008 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 200MG BASE Discontinued No No AB 2023/08/11 LUPIN
>>>活性成分:DOXYCYCLINE HYCLATE; 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL; 规格:EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 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
050795 006 NDA DORYX DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2014/12/19 MAYNE PHARMA
>>>活性成分:DOXYCYCLINE HYCLATE; 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL; 规格:EQ 60MG 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
050795 007 NDA DORYX MPC DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 60MG BASE Prescription Yes No AB 2016/05/20 MAYNE PHARMA
208741 002 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE;ORAL EQ 60MG BASE Discontinued No No AB 2023/08/11 LUPIN
更多信息
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