药品注册申请号：014399
申请类型：NDA (新药申请)
申请人：VALIDUS PHARMS
申请人全名：VALIDUS PHARMACEUTICALS 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 NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Yes No AB 1964/11/20 Approved Prior to Jan 1, 1982 Prescription
003 NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
004 NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 75MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
005 NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 100MG Yes Yes AB Approved Prior to Jan 1, 1982 Prescription
006 NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 150MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
007 NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Yes No AB 1982/02/11 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
2018/11/09 SUPPL-71（补充） Approval Labeling STANDARD
2014/08/07 SUPPL-68（补充） Approval Manufacturing (CMC) STANDARD
2014/07/02 SUPPL-69（补充） Approval Labeling 901 REQUIRED
2012/11/19 SUPPL-67（补充） Approval Labeling STANDARD
2012/11/19 SUPPL-66（补充） Approval Labeling UNKNOWN
2009/10/26 SUPPL-65（补充） Approval Labeling UNKNOWN
2007/07/30 SUPPL-64（补充） Approval Labeling STANDARD
2006/04/11 SUPPL-63（补充） Approval Labeling STANDARD
2005/01/12 SUPPL-62（补充） Approval Labeling STANDARD
2000/05/23 SUPPL-61（补充） Approval Labeling STANDARD
2000/05/23 SUPPL-60（补充） Approval Labeling STANDARD
2000/05/23 SUPPL-58（补充） Approval Labeling STANDARD
2000/05/23 SUPPL-55（补充） Approval Labeling
1992/09/03 SUPPL-56（补充） Approval Manufacturing (CMC) STANDARD
1991/12/11 SUPPL-53（补充） Approval Labeling
1991/12/11 SUPPL-52（补充） Approval Labeling
1990/12/10 SUPPL-49（补充） Approval Labeling
1990/12/10 SUPPL-42（补充） Approval Labeling
1990/04/25 SUPPL-50（补充） Approval Manufacturing (CMC) STANDARD
1989/06/19 SUPPL-51（补充） Approval Manufacturing (CMC) STANDARD
1989/03/21 SUPPL-48（补充） Approval Manufacturing (CMC) STANDARD
1988/11/15 SUPPL-45（补充） Approval Manufacturing (CMC) STANDARD
1988/06/20 SUPPL-46（补充） Approval Manufacturing (CMC) STANDARD
1988/03/30 SUPPL-47（补充） Approval Manufacturing (CMC) STANDARD
1987/04/03 SUPPL-44（补充） Approval Manufacturing (CMC) STANDARD
1986/06/24 SUPPL-43（补充） Approval Manufacturing (CMC) STANDARD
1985/04/29 SUPPL-40（补充） Approval Labeling
1982/06/22 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
1982/06/22 SUPPL-37（补充） Approval Manufacturing (CMC) STANDARD
1982/02/11 SUPPL-33（补充） Approval Manufacturing (CMC) STANDARD
1982/02/01 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
1982/02/01 SUPPL-35（补充） Approval Manufacturing (CMC) STANDARD
1982/02/01 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
1982/02/01 SUPPL-32（补充） Approval Manufacturing (CMC) STANDARD
1980/08/18 SUPPL-30（补充） Approval Labeling
1980/07/28 SUPPL-31（补充） Approval Labeling
1980/02/14 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1977/03/01 SUPPL-27（补充） Approval Labeling
1976/06/25 SUPPL-20（补充） Approval Efficacy
1976/05/28 SUPPL-22（补充） Approval Labeling
1975/10/06 SUPPL-23（补充） Approval Labeling
1975/04/15 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1975/04/04 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
1974/07/02 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1964/11/20 ORIG-1（原始申请） Approval Type 2 - New Active Ingredient 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
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:DESIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:25MG 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
014399 001 NDA NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
071601 001 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 1987/06/05 ACTAVIS TOTOWA
072103 003 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 1988/05/24 CHARTWELL RX
208105 002 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2016/03/17 AMNEAL PHARMS CO
207433 002 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2016/05/05 HERITAGE PHARMS
204963 002 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2017/12/26 NOVAST LABS
209785 002 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2021/07/07 ALEMBIC
活性成分:DESIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 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
014399 003 NDA NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
071588 001 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 1987/06/05 ACTAVIS TOTOWA
072103 004 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 1988/05/24 CHARTWELL RX
208105 003 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2016/03/17 AMNEAL PHARMS CO
207433 003 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2016/05/05 HERITAGE PHARMS
204963 003 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2017/12/26 NOVAST LABS
209785 003 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2021/07/07 ALEMBIC
活性成分:DESIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:75MG 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
014399 004 NDA NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
071602 001 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 1987/10/05 ACTAVIS TOTOWA
072103 005 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 1988/06/20 CHARTWELL RX
208105 004 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2016/03/17 AMNEAL PHARMS CO
207433 004 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2016/05/05 HERITAGE PHARMS
204963 004 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2017/12/26 NOVAST LABS
209785 004 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2021/07/07 ALEMBIC
活性成分:DESIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:100MG 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
014399 005 NDA NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
071766 001 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 1987/10/05 ACTAVIS TOTOWA
072103 001 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 1988/06/20 CHARTWELL RX
208105 005 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2016/03/17 AMNEAL PHARMS CO
207433 005 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2016/05/05 HERITAGE PHARMS
204963 005 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2017/12/26 NOVAST LABS
209785 005 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2021/07/07 ALEMBIC
活性成分:DESIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:150MG 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
014399 006 NDA NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
072103 006 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 1988/06/20 CHARTWELL RX
074430 002 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 1996/02/09 ACTAVIS TOTOWA
208105 006 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2016/03/17 AMNEAL PHARMS CO
207433 006 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2016/05/05 HERITAGE PHARMS
204963 006 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2017/12/26 NOVAST LABS
209785 006 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2021/07/07 ALEMBIC
活性成分:DESIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 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
014399 007 NDA NORPRAMIN DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription Yes No AB 1982/02/11 VALIDUS PHARMS
072103 002 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1988/05/24 CHARTWELL RX
074430 001 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1996/02/09 ACTAVIS TOTOWA
208105 001 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2016/03/17 AMNEAL PHARMS CO
207433 001 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2016/05/05 HERITAGE PHARMS
204963 001 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2017/12/26 NOVAST LABS
209785 001 ANDA DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/07/07 ALEMBIC
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