药品注册申请号:008708
申请类型:NDA (新药申请)
申请人:CONCORDIA
申请人全名:CONCORDIA PHARMACEUTICALS 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 DIBENZYLINE PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Yes No AB 1953/01/26 Approved Prior to Jan 1, 1982 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
2008/04/03 SUPPL-25(补充) Approval Labeling STANDARD
2003/12/30 SUPPL-23(补充) Approval Labeling STANDARD
2003/01/15 SUPPL-22(补充) Approval Labeling STANDARD
2001/03/30 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
1995/02/03 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1991/07/12 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1991/03/01 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
1988/07/28 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1987/05/27 SUPPL-15(补充) Approval Labeling
1984/05/25 SUPPL-16(补充) Approval Labeling
1983/03/15 SUPPL-12(补充) Approval Labeling
1953/01/26 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
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
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
与本品治疗等效的药品
活性成分:PHENOXYBENZAMINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;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
008708 001 NDA DIBENZYLINE PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription Yes No AB Approved Prior to Jan 1, 1982 CONCORDIA
201050 001 ANDA PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Discontinued No No AB 2012/07/16 HIKMA
204522 001 ANDA PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No Yes AB 2017/01/24 ENDO OPERATIONS
212568 001 ANDA PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No No AB 2020/10/27 AMNEAL
215042 001 ANDA PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No No AB 2022/07/19 NOVITIUM PHARMA
215600 001 ANDA PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No No AB 2023/05/08 AUROBINDO PHARMA
204551 001 ANDA PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No No AB 2023/06/20 RISING
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