药品注册申请号：213559
申请类型：ANDA (仿制药申请)
申请人：QUAGEN
申请人全名：QUAGEN PHARMACEUTICALS 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 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.025% No No AT 2020/07/01 2020/07/01 Prescription
002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.1% No No AT 2020/07/01 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
2020/07/01 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
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:TRIAMCINOLONE ACETONIDE 剂型/给药途径:LOTION;TOPICAL 规格:0.025% 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
088450 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.025% Prescription No Yes AT 1985/04/01 WOCKHARDT BIO AG
040467 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.025% Prescription No No AT 2003/04/21 FOUGERA PHARMS
202374 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.025% Prescription No No AT 2013/05/08 EPIC PHARMA LLC
204608 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.025% Discontinued No No AT 2016/07/07 PAI HOLDINGS PHARM
213559 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.025% Prescription No No AT 2020/07/01 QUAGEN
活性成分:TRIAMCINOLONE ACETONIDE 剂型/给药途径:LOTION;TOPICAL 规格:0.1% 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
088451 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.1% Prescription No Yes AT 1985/04/03 WOCKHARDT BIO AG
089129 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.1% Prescription No No AT 1986/08/14 COSETTE
040467 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.1% Prescription No No AT 2003/04/21 FOUGERA PHARMS
040672 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.1% Prescription No No AT 2006/12/13 MICRO LABS
202374 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.1% Prescription No No AT 2013/05/08 EPIC PHARMA LLC
204606 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.1% Discontinued No No AT 2016/07/07 PAI HOLDINGS PHARM
213559 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE LOTION;TOPICAL 0.1% Prescription No No AT 2020/07/01 QUAGEN
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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