药品注册申请号：091424
申请类型：ANDA (仿制药申请)
申请人：CHARTWELL RX
申请人全名：CHARTWELL RX SCIENCES 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 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 45MG BASE No No AB;AB 2011/11/30 2011/11/30 Prescription
002 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE No No AB;AB 2011/11/30 Prescription
003 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 90MG BASE No No AB;AB 2011/11/30 Prescription
004 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE No No AB;AB 2011/11/30 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
2016/09/27 SUPPL-2（补充） Approval Labeling STANDARD
2016/04/13 SUPPL-1（补充） Approval Labeling STANDARD
2011/11/30 ORIG-2（原始申请） Tentative Approval
2011/11/30 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
002 PC 2019/08/21**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: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 SUN PHARM
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 SUN PHARM
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 Discontinued 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 SUN PHARM
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 Discontinued 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 SUN PHARM
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 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 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 No 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 SUN PHARM
204453 005 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No Yes 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 No 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 SUN PHARM
204453 005 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 135MG BASE Prescription No Yes 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
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database