药品注册申请号：065005
申请类型：ANDA (仿制药申请)
申请人：IMPAX LABS
申请人全名：IMPAX LABORATORIES 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 CAPSULE;ORAL EQ 50MG BASE No No AB 1999/03/23 1999/03/23 Prescription
002 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE No No AB 1999/03/23 Prescription
003 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE No No AB 2001/04/18 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
>>>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
1999/03/23 ORIG-1（原始申请） Approval
>>>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
2011/06/15 SUPPL-11（补充） Approval Labeling-Package Insert
2004/04/19 SUPPL-8（补充） Approval Labeling
2004/04/13 SUPPL-7（补充） Approval Labeling
2001/12/06 SUPPL-4（补充） Approval Manufacturing (CMC)-Facility
2001/04/18 SUPPL-3（补充） Approval Labeling
2001/04/18 SUPPL-2（补充） Approval Manufacturing (CMC)-Packaging
2001/04/18 SUPPL-1（补充） Approval Manufacturing (CMC)-New Strength
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:CAPSULE;ORAL; 规格:EQ 50MG 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
050649 001 NDA MINOCIN MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription Yes No AB 1990/05/31 BAUSCH
063067 003 ANDA DYNACIN MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Discontinued No No AB 1990/08/14 ALVOGEN
063181 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 1991/12/30 WATSON LABS TEVA
063011 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 1992/03/02 ZYDUS
065005 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 1999/03/23 IMPAX LABS
065062 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2000/11/30 TORRENT
065470 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2008/03/11 AUROBINDO PHARMA
090867 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Discontinued No No AB 2013/05/13 SUN PHARM INDS INC
>>>活性成分:MINOCYCLINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 100MG 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
050649 002 NDA MINOCIN MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription Yes No AB 1990/05/31 BAUSCH
063067 001 ANDA DYNACIN MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Discontinued No No AB 1990/07/31 ALVOGEN
063065 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 1991/12/30 WATSON LABS
063009 001 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No Yes AB 1992/03/02 ZYDUS
065005 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 1999/03/23 IMPAX LABS
065062 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2000/11/30 TORRENT
065470 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2008/03/11 AUROBINDO PHARMA
090867 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE Discontinued No No AB 2013/05/13 SUN PHARM INDS INC
>>>活性成分:MINOCYCLINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 75MG 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
063065 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 1999/06/10 WATSON LABS
063067 002 ANDA DYNACIN MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Discontinued No No AB 1999/09/15 ALVOGEN
065062 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2000/11/30 TORRENT
065005 003 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2001/04/18 IMPAX LABS
063009 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2003/08/12 ZYDUS
065470 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2008/03/11 AUROBINDO PHARMA
090867 002 ANDA MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Discontinued No No AB 2013/05/13 SUN PHARM INDS INC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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