药品注册申请号：203553
申请类型：ANDA (仿制药申请)
申请人：ZYDUS PHARMS
申请人全名：ZYDUS PHARMACEUTICALS USA INC
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 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE No No AB;AB 2017/11/16 2017/11/16 Discontinued
002 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE No No AB;AB 2023/06/16 Discontinued
003 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 65MG BASE No No AB;AB 2023/06/16 Discontinued
004 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 80MG BASE No No AB;AB 2017/11/16 Discontinued
005 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE No No AB;AB 2017/11/16 Discontinued
006 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 105MG BASE No No AB;AB 2017/11/16 Discontinued
007 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 115MG BASE No No AB;AB 2023/06/16 Discontinued
008 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE No No AB;AB 2017/11/16 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
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
2023/06/16 ORIG-2（原始申请） Approval
2017/11/16 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
无
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 45MG 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
090422 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Prescription No No AB 2009/08/13 SANDOZ
091424 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Prescription No No AB 2011/11/30 CHARTWELL RX
202261 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Prescription No No AB 2012/11/19 AUROBINDO PHARMA LTD
091118 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Discontinued No No AB 2014/09/25 SUN PHARM INDS LTD
204394 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Prescription No No AB 2015/12/30 SIDMAK LABS INDIA
204453 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Prescription No No AB 2016/09/28 ALKEM LABS LTD
203553 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG 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 45MG 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
090422 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Prescription No No AB 2009/08/13 SANDOZ
091424 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Prescription No No AB 2011/11/30 CHARTWELL RX
202261 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Prescription No No AB 2012/11/19 AUROBINDO PHARMA LTD
091118 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Discontinued No No AB 2014/09/25 SUN PHARM INDS LTD
204394 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Prescription No No AB 2015/12/30 SIDMAK LABS INDIA
204453 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE Prescription No No AB 2016/09/28 ALKEM LABS LTD
203553 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG 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
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
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 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 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 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 90MG 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
090422 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE Prescription No No AB 2009/08/13 SANDOZ
091424 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE Prescription No No AB 2011/11/30 CHARTWELL RX
202261 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE Prescription No No AB 2012/11/19 AUROBINDO PHARMA LTD
091118 005 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE Discontinued No No AB 2014/09/25 SUN PHARM INDS LTD
204453 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE Prescription No No AB 2016/09/28 ALKEM LABS LTD
203553 005 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG 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 90MG 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
090422 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE Prescription No No AB 2009/08/13 SANDOZ
091424 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE Prescription No No AB 2011/11/30 CHARTWELL RX
202261 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE Prescription No No AB 2012/11/19 AUROBINDO PHARMA LTD
091118 005 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE Discontinued No No AB 2014/09/25 SUN PHARM INDS LTD
204453 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE Prescription No No AB 2016/09/28 ALKEM LABS LTD
203553 005 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG 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 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 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 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 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 135MG 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
090422 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No Yes AB 2009/08/13 SANDOZ
091424 004 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No No AB 2011/11/30 CHARTWELL RX
202261 005 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No No AB 2012/11/19 AUROBINDO PHARMA LTD
091118 008 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Discontinued No No AB 2014/09/25 SUN PHARM INDS LTD
204394 007 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No No AB 2015/12/30 SIDMAK LABS INDIA
204453 005 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No No AB 2016/09/28 ALKEM LABS LTD
203553 008 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG 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 135MG 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
090422 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No Yes AB 2009/08/13 SANDOZ
091424 004 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No No AB 2011/11/30 CHARTWELL RX
202261 005 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No No AB 2012/11/19 AUROBINDO PHARMA LTD
091118 008 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Discontinued No No AB 2014/09/25 SUN PHARM INDS LTD
204394 007 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No No AB 2015/12/30 SIDMAK LABS INDIA
204453 005 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No No AB 2016/09/28 ALKEM LABS LTD
203553 008 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Discontinued No No AB 2017/11/16 ZYDUS PHARMS
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