药品注册申请号：073556
申请类型：ANDA (仿制药申请)
申请人：DR REDDYS LABS SA
申请人全名：DR REDDYS LABORATORIES SA
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 NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE No No AB 1992/03/30 1992/03/30 Prescription
002 NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE No No AB 1992/03/30 Prescription
003 NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE No No AB 1992/03/30 Prescription
004 NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE No No AB 1992/03/30 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
>>>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
1992/03/30 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
2020/02/21 SUPPL-55（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2015/07/15 SUPPL-52（补充） Approval Labeling-Package Insert STANDARD
2015/07/15 SUPPL-50（补充） Approval Labeling-Package Insert STANDARD
2008/02/20 SUPPL-34（补充） Approval Labeling
2007/07/03 SUPPL-32（补充） Approval Labeling
2007/04/12 SUPPL-29（补充） Approval Labeling
2006/11/01 SUPPL-24（补充） Approval Labeling
2005/07/26 SUPPL-22（补充） Approval Labeling
2002/01/04 SUPPL-16（补充） Approval Labeling
2001/04/25 SUPPL-15（补充） Approval Manufacturing (CMC)-Control
1998/08/26 SUPPL-13（补充） Approval Manufacturing (CMC)
1998/08/26 SUPPL-12（补充） Approval Manufacturing (CMC)
1997/02/07 SUPPL-11（补充） Approval Labeling
1995/12/05 SUPPL-10（补充） Approval Labeling
1995/07/11 SUPPL-8（补充） Approval Manufacturing (CMC)
1995/05/25 SUPPL-9（补充） Approval Manufacturing (CMC)
1995/05/25 SUPPL-7（补充） Approval Manufacturing (CMC)
1995/02/16 SUPPL-6（补充） Approval Manufacturing (CMC)
1995/02/16 SUPPL-5（补充） Approval Manufacturing (CMC)
1993/08/31 SUPPL-4（补充） Approval Labeling
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:NORTRIPTYLINE 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
018013 003 NDA PAMELOR NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Discontinued Yes No AB Approved Prior to Jan 1, 1982 SPECGX LLC
073556 001 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 1992/03/30 DR REDDYS LABS SA
074132 004 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No Yes AB 1995/03/27 TEVA
075520 002 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2000/05/08 TARO
>>>活性成分:NORTRIPTYLINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 10MG 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
018013 001 NDA PAMELOR NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Discontinued Yes No AB Approved Prior to Jan 1, 1982 SPECGX LLC
073556 002 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 1992/03/30 DR REDDYS LABS SA
074132 001 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 1995/03/27 TEVA
075520 004 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE Prescription No No AB 2000/05/08 TARO
>>>活性成分:NORTRIPTYLINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 25MG 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
018013 002 NDA PAMELOR NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Discontinued Yes No AB Approved Prior to Jan 1, 1982 SPECGX LLC
073556 003 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 1992/03/30 DR REDDYS LABS SA
074132 002 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 1995/03/27 TEVA
075520 003 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2000/05/08 TARO
>>>活性成分:NORTRIPTYLINE 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
018013 004 NDA PAMELOR NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Discontinued Yes No AB Approved Prior to Jan 1, 1982 SPECGX LLC
073556 004 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 1992/03/30 DR REDDYS LABS SA
074132 003 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 1995/03/27 TEVA
075520 001 ANDA NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2000/05/08 TARO
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
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