药品注册申请号:065175
申请类型:ANDA (仿制药申请)
申请人:ADRASTEA PHARMA
申请人全名:ADRASTEA PHARMA 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 NYSTATIN NYSTATIN POWDER;TOPICAL 100,000 UNITS/GM No No AT 2004/12/17 2004/12/17 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
2007/07/23 SUPPL-4(补充) Approval Labeling
2004/12/17 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:NYSTATIN 剂型/给药途径:POWDER;TOPICAL 规格:100,000 UNITS/GM 治疗等效代码:AT
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
064118 001 ANDA NYSTOP NYSTATIN POWDER;TOPICAL 100,000 UNITS/GM Prescription No No AT 1996/08/16 PADAGIS US
065203 001 ANDA NYSTATIN NYSTATIN POWDER;TOPICAL 100,000 UNITS/GM Prescription No Yes AT 2004/07/15 DR REDDYS LABS SA
065138 001 ANDA NYSTATIN NYSTATIN POWDER;TOPICAL 100,000 UNITS/GM Prescription No No AT 2004/07/23 LUPIN
065175 001 ANDA NYSTATIN NYSTATIN POWDER;TOPICAL 100,000 UNITS/GM Prescription No No AT 2004/12/17 ADRASTEA PHARMA
065183 001 ANDA NYSTATIN NYSTATIN POWDER;TOPICAL 100,000 UNITS/GM Prescription No No AT 2005/05/03 UPSHER SMITH LABS
208838 001 ANDA NYSTATIN NYSTATIN POWDER;TOPICAL 100,000 UNITS/GM Prescription No No AT 2017/05/30 LYNE
208581 001 ANDA NYSTATIN NYSTATIN POWDER;TOPICAL 100,000 UNITS/GM Prescription No No AT 2017/06/08 ZYDUS PHARMS
210532 001 ANDA NYSTATIN NYSTATIN POWDER;TOPICAL 100,000 UNITS/GM Prescription No No AT 2018/04/30 EPIC PHARMA LLC
更多信息
药品NDC数据与药品包装、标签说明书
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