药品注册申请号:204414
申请类型:ANDA (仿制药申请)
申请人:INVAGEN PHARMS
申请人全名:INVAGEN 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 PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG No No AA 2014/05/05 2014/05/05 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
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
2017/05/31 SUPPL-1(补充) Approval Labeling STANDARD
2014/05/05 ORIG-1(原始申请) Approval
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:PHENTERMINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:30MG 治疗等效代码:AA
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
087190 001 ANDA PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription Yes Yes AA Approved Prior to Jan 1, 1982 SANDOZ
087022 001 ANDA PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG Discontinued No No AA 1983/02/03 LANNETT
086945 001 ANDA PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription Yes Yes AA 1983/07/20 SANDOZ
040525 001 ANDA PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG Discontinued No No AA 2003/10/23 SUN PHARM INDUSTRIES
040875 001 ANDA PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription No No AA 2008/03/21 KVK TECH
040886 001 ANDA PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription No No AA 2008/03/31 KVK TECH
202248 002 ANDA PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription No No AA 2012/09/28 ELITE LABS
202858 002 ANDA PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG Discontinued No No AA 2014/02/14 INVAGEN PHARMS
204414 001 ANDA PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG Discontinued No No AA 2014/05/05 INVAGEN PHARMS
205019 002 ANDA PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription No No AA 2014/12/05 NUVO PHARM
204318 002 ANDA PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL 30MG Prescription No No AA 2016/11/09 AUROLIFE PHARMA LLC
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药品NDC数据与药品包装、标签说明书
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