药品注册申请号:209390
申请类型:ANDA (仿制药申请)
申请人:TWI PHARMS
申请人全名:TWI 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 TESTOSTERONE TESTOSTERONE GEL, METERED;TRANSDERMAL 1.62% (20.25MG/1.25GM ACTUATION) No No AB 2019/09/23 2019/09/23 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
2019/09/23 ORIG-1(原始申请) Approval 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
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:TESTOSTERONE 剂型/给药途径:GEL, METERED;TRANSDERMAL 规格:1.62% (20.25MG/1.25GM ACTUATION) 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
022309 001 NDA ANDROGEL TESTOSTERONE GEL, METERED;TRANSDERMAL 1.62% (20.25MG/1.25GM ACTUATION) Prescription Yes Yes AB 2011/04/29 BESINS HLTHCARE
204268 001 ANDA TESTOSTERONE TESTOSTERONE GEL, METERED;TRANSDERMAL 1.62% (20.25MG/1.25GM ACTUATION) Prescription No No AB 2015/08/04 PADAGIS ISRAEL
204570 001 ANDA TESTOSTERONE TESTOSTERONE GEL, METERED;TRANSDERMAL 1.62% (20.25MG/1.25GM ACTUATION) Prescription No No AB 2019/04/10 ACTAVIS LABS UT INC
207373 001 ANDA TESTOSTERONE TESTOSTERONE GEL, METERED;TRANSDERMAL 1.62% (20.25MG/1.25GM ACTUATION) Prescription No No AB 2019/04/10 AMNEAL
208560 001 ANDA TESTOSTERONE TESTOSTERONE GEL, METERED;TRANSDERMAL 1.62% (20.25MG/1.25GM ACTUATION) Prescription No No AB 2019/04/10 LUPIN
208620 001 ANDA TESTOSTERONE TESTOSTERONE GEL, METERED;TRANSDERMAL 1.62% (20.25MG/1.25GM ACTUATION) Prescription No No AB 2019/04/10 ENCUBE
209390 001 ANDA TESTOSTERONE TESTOSTERONE GEL, METERED;TRANSDERMAL 1.62% (20.25MG/1.25GM ACTUATION) Prescription No No AB 2019/09/23 TWI PHARMS
210835 001 ANDA TESTOSTERONE TESTOSTERONE GEL, METERED;TRANSDERMAL 1.62% (20.25MG/1.25GM ACTUATION) Prescription No No AB 2020/04/16 XIROMED
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