药品注册申请号：050808
申请类型：NDA (新药申请)
申请人：BAUSCH
申请人全名：BAUSCH HEALTH US LLC
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 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2006/05/08 2006/05/08 Discontinued
002 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2006/05/08 Discontinued
003 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2006/05/08 Discontinued
004 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2009/07/23 Discontinued
005 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2009/07/23 Discontinued
006 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2010/08/27 Discontinued
007 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2010/08/27 Discontinued
008 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2010/08/27 Discontinued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
2006/05/08 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
2025/04/01 SUPPL-28（补充） Approval Labeling-Package Insert STANDARD
2025/03/18 SUPPL-27（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2025/03/18 SUPPL-24（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2016/02/03 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
2014/07/15 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
2013/10/21 SUPPL-23（补充） Approval Labeling-Package Insert STANDARD
2013/04/17 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
2011/04/20 SUPPL-15（补充） Approval Labeling-Container/Carton Labels STANDARD
2011/03/18 SUPPL-14（补充） Approval Labeling UNKNOWN
2010/08/07 SUPPL-13（补充） Approval Labeling STANDARD
2009/12/30 SUPPL-11（补充） Approval Labeling STANDARD
2009/07/23 SUPPL-7（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert N/A
2007/02/27 SUPPL-3（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels N/A
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 7790705 2025/06/24 U-1078 PDF格式
7919483 2027/03/07 U-1078 PDF格式
8252776 2025/06/24 U-124 2012/08/28 PDF格式
8268804 2025/06/24 U-1078 2012/10/09 PDF格式
002 7541347 2027/04/02 U-917 PDF格式
7544373 2027/04/02 Y PDF格式
7790705 2025/06/24 U-1078 PDF格式
7919483 2027/03/07 U-1078 PDF格式
8252776 2025/06/24 U-124 PDF格式
8268804 2025/06/24 U-1078 PDF格式
003 7790705 2025/06/24 U-1078 PDF格式
7919483 2027/03/07 U-1078 PDF格式
8252776 2025/06/24 U-124 PDF格式
8268804 2025/06/24 U-1078 PDF格式
004 7790705 2025/06/24 U-1078 PDF格式
7919483 2027/03/07 U-1078 PDF格式
8252776 2025/06/24 U-124 PDF格式
8268804 2025/06/24 U-1078 PDF格式
9192615 2031/11/17 Y 2016/01/08 PDF格式
005 7790705 2025/06/24 U-1078 PDF格式
7919483 2027/03/07 U-1078 PDF格式
8252776 2025/06/24 U-124 PDF格式
8268804 2025/06/24 U-1078 PDF格式
9192615 2031/11/17 Y 2016/01/08 PDF格式
006 7790705 2025/06/24 U-1078 PDF格式
7919483 2027/03/07 U-1078 PDF格式
8252776 2025/06/24 U-124 PDF格式
8268804 2025/06/24 U-1078 PDF格式
8722650 2025/06/24 U-1078 PDF格式
007 7790705 2025/06/24 U-1078 PDF格式
7919483 2027/03/07 U-1078 PDF格式
8252776 2025/06/24 U-124 PDF格式
8268804 2025/06/24 U-1078 PDF格式
8722650 2025/06/24 U-1078 PDF格式
008 7790705 2025/06/24 U-1078 PDF格式
7919483 2027/03/07 U-1078 PDF格式
8252776 2025/06/24 U-124 PDF格式
8268804 2025/06/24 U-1078 PDF格式
8722650 2025/06/24 U-1078 PDF格式
001 5908838 2018/02/19 U-917 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5908838 2018/02/19 U-917 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5908838 2018/02/19 U-917 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5908838 2018/02/19 U-917 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5908838 2018/02/19 U-917 PDF格式**本条是由Drugfuture回溯的历史信息**
006 5908838 2018/02/19 U-917 PDF格式**本条是由Drugfuture回溯的历史信息**
007 5908838 2018/02/19 U-917 PDF格式**本条是由Drugfuture回溯的历史信息**
008 5908838 2018/02/19 U-917 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
无
与本品治疗等效的药品
>>>活性成分:MINOCYCLINE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:EQ 65MG 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
050808 004 NDA SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2009/07/23 BAUSCH
>>>活性成分:MINOCYCLINE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:EQ 115MG 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
050808 005 NDA SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2009/07/23 BAUSCH
>>>活性成分:MINOCYCLINE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:EQ 105MG 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
050808 006 NDA SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2010/08/27 BAUSCH
>>>活性成分:MINOCYCLINE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:EQ 80MG 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
050808 007 NDA SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2010/08/27 BAUSCH
>>>活性成分:MINOCYCLINE HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:EQ 55MG 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
050808 008 NDA SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 2010/08/27 BAUSCH
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药品NDC数据与药品包装、标签说明书
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