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TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2006/05/08 2006/05/08 Discontinued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TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2006/05/08 Discontinued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TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2006/05/08 Discontinued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 Yes No AB 2009/07/23 Prescription
005 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 115MG BASE Yes Yes AB 2009/07/23 Prescription
006 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 105MG BASE Yes No AB 2010/08/27 Prescription
007 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 80MG BASE Yes No AB 2010/08/27 Prescription
008 SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE Yes No AB 2010/08/27 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
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 STANDARD
2013/04/17 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
2011/04/20 SUPPL-15（补充） Approval Labeling 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 Manufacturing (CMC) N/A
2007/02/27 SUPPL-3（补充） Approval Manufacturing (CMC) N/A
2006/05/08 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
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 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 Prescription Yes No AB 2009/07/23 BAUSCH
204453 006 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 65MG BASE Prescription No No AB 2018/03/16 ALKEM LABS LTD
202261 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 65MG BASE Prescription No No AB 2018/09/28 AUROBINDO PHARMA LTD
091118 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 65MG BASE Discontinued No No AB 2019/12/03 SUN PHARM INDS LTD
204394 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 65MG BASE Prescription No No AB 2022/10/07 SIDMAK LABS INDIA
203553 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 65MG BASE Discontinued No No AB 2023/06/16 ZYDUS PHARMS
活性成分:MINOCYCLINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 115MG 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
050808 005 NDA SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 115MG BASE Prescription Yes Yes AB 2009/07/23 BAUSCH
204453 007 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 115MG BASE Prescription No No AB 2018/03/16 ALKEM LABS LTD
202261 004 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 115MG BASE Prescription No No AB 2018/09/28 AUROBINDO PHARMA LTD
091118 007 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 115MG BASE Discontinued No No AB 2019/12/03 SUN PHARM INDS LTD
204394 006 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 115MG BASE Prescription No No AB 2022/10/07 SIDMAK LABS INDIA
203553 007 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 115MG BASE Discontinued No No AB 2023/06/16 ZYDUS PHARMS
活性成分:MINOCYCLINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 105MG 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
050808 006 NDA SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 105MG BASE Prescription Yes No AB 2010/08/27 BAUSCH
091118 006 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 105MG BASE Discontinued No No AB 2014/09/25 SUN PHARM INDS LTD
204394 005 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 105MG BASE Prescription No No AB 2015/12/30 SIDMAK LABS INDIA
202261 007 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 105MG BASE Prescription No No AB 2016/06/13 AUROBINDO PHARMA LTD
204453 004 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 105MG BASE Prescription No No AB 2016/09/28 ALKEM LABS LTD
203553 006 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 105MG BASE Discontinued No No AB 2017/11/16 ZYDUS PHARMS
活性成分:MINOCYCLINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED 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
050808 007 NDA SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 80MG BASE Prescription Yes No AB 2010/08/27 BAUSCH
091118 004 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 80MG BASE Discontinued No No AB 2014/09/25 SUN PHARM INDS LTD
204394 004 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 80MG BASE Prescription No No AB 2015/12/30 SIDMAK LABS INDIA
202261 006 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 80MG BASE Prescription No No AB 2016/06/13 AUROBINDO PHARMA LTD
204453 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 80MG BASE Prescription No No AB 2016/09/28 ALKEM LABS LTD
203553 004 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 80MG BASE Discontinued No No AB 2017/11/16 ZYDUS PHARMS
活性成分:MINOCYCLINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 55MG 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
050808 008 NDA SOLODYN MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE Prescription Yes No AB 2010/08/27 BAUSCH
091424 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE Prescription No No AB 2011/11/30 CHARTWELL RX
202261 008 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE Prescription No No AB 2019/08/21 AUROBINDO PHARMA LTD
204453 008 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE Prescription No No AB 2019/12/19 ALKEM LABS LTD
204394 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE Prescription No No AB 2022/10/07 SIDMAK LABS INDIA
203553 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE Discontinued No No AB 2023/06/16 ZYDUS PHARMS
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