药品注册申请号：074947
申请类型：ANDA (仿制药申请)
申请人：PHARMOBEDIENT
申请人全名：PHARMOBEDIENT CONSULTING 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 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG No No AB 1998/04/30 1998/04/30 Discontinued
002 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG No No AB 1998/04/30 Discontinued
003 CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG No No AB 1998/04/30 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
>>>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
1998/04/30 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
2016/12/29 SUPPL-16（补充） Approval Labeling-Package Insert STANDARD
2013/03/18 SUPPL-15（补充） Approval Labeling-Package Insert STANDARD
2007/10/16 SUPPL-10（补充） Approval Labeling
2007/07/09 SUPPL-8（补充） Approval Labeling
2005/05/03 SUPPL-4（补充） Approval Labeling
2003/10/31 SUPPL-3（补充） Approval Labeling
2001/12/11 SUPPL-2（补充） Approval Labeling
2001/08/03 SUPPL-1（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:CLOMIPRAMINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;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
019906 001 NDA ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription Yes Yes AB 1989/12/29 SPECGX LLC
074364 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 1996/03/29 CHARTWELL RX
074694 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 1996/12/31 TARO
074953 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 1997/06/25 SANDOZ
074947 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Discontinued No No AB 1998/04/30 PHARMOBEDIENT
208961 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 2017/12/27 ZYDUS PHARMS
208632 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Discontinued No No AB 2018/10/31 AMNEAL PHARMS CO
209294 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 2018/11/21 LUPIN LTD
211767 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 2019/04/08 MANKIND PHARMA
212218 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 2019/10/21 JUBILANT CADISTA
211364 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 2020/02/07 IXORA LIFESCIENCE
210653 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 2020/04/03 TP ANDA HOLDINGS
213219 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 2020/06/22 MICRO LABS
213221 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Discontinued No No AB 2020/06/22 RK PHARMA
212285 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 2020/08/07 UNIQUE
213897 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Discontinued No No AB 2020/10/02 AJANTA PHARMA LTD
211822 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 2021/08/04 ALEMBIC
216440 001 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG Prescription No No AB 2023/03/20 AUROBINDO PHARMA
>>>活性成分:CLOMIPRAMINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;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
019906 002 NDA ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription Yes No AB 1989/12/29 SPECGX LLC
074364 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 1996/03/29 CHARTWELL RX
074694 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 1996/12/31 TARO
074953 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 1997/06/25 SANDOZ
074947 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Discontinued No No AB 1998/04/30 PHARMOBEDIENT
208961 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 2017/12/27 ZYDUS PHARMS
208632 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Discontinued No No AB 2018/10/31 AMNEAL PHARMS CO
209294 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 2018/11/21 LUPIN LTD
211767 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 2019/04/08 MANKIND PHARMA
212218 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 2019/10/21 JUBILANT CADISTA
211364 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 2020/02/07 IXORA LIFESCIENCE
210653 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 2020/04/03 TP ANDA HOLDINGS
213219 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 2020/06/22 MICRO LABS
213221 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Discontinued No No AB 2020/06/22 RK PHARMA
212285 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 2020/08/07 UNIQUE
213897 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Discontinued No No AB 2020/10/02 AJANTA PHARMA LTD
211822 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 2021/08/04 ALEMBIC
216440 002 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG Prescription No No AB 2023/03/20 AUROBINDO PHARMA
>>>活性成分:CLOMIPRAMINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;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
019906 003 NDA ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription Yes No AB 1989/12/29 SPECGX LLC
074364 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 1996/03/29 CHARTWELL RX
074694 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 1996/12/31 TARO
074953 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 1997/06/25 SANDOZ
074947 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Discontinued No No AB 1998/04/30 PHARMOBEDIENT
208961 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 2017/12/27 ZYDUS PHARMS
208632 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Discontinued No No AB 2018/10/31 AMNEAL PHARMS CO
209294 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 2018/11/21 LUPIN LTD
211767 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 2019/04/08 MANKIND PHARMA
212218 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 2019/10/21 JUBILANT CADISTA
211364 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 2020/02/07 IXORA LIFESCIENCE
210653 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 2020/04/03 TP ANDA HOLDINGS
213219 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 2020/06/22 MICRO LABS
213221 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Discontinued No No AB 2020/06/22 RK PHARMA
212285 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 2020/08/07 UNIQUE
213897 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Discontinued No No AB 2020/10/02 AJANTA PHARMA LTD
211822 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 2021/08/04 ALEMBIC
216440 003 ANDA CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 75MG Prescription No No AB 2023/03/20 AUROBINDO PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
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