药品注册申请号：209535
申请类型：ANDA (仿制药申请)
申请人：MACLEODS PHARMS LTD
申请人全名：MACLEODS PHARMACEUTICALS LTD
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 CREAM;TOPICAL 0.025% No No AT 2018/05/18 2018/05/18 Prescription
002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% No No AT 2018/05/18 Prescription
003 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.5% No No AT 2018/05/18 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
2022/11/08 SUPPL-12（补充） Approval Manufacturing (CMC) UNKNOWN
2018/05/18 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:CREAM;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
085692 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 FOUGERA PHARMS
086413 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT Approved Prior to Jan 1, 1982 PADAGIS US
089797 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT 1991/05/31 COSETTE
040671 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT 2006/06/09 MICRO LABS
088042 002 ANDA TRIDERM TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT 2015/03/25 CROWN LABS
208763 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT 2017/02/01 CHARTWELL RX
207651 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT 2017/12/26 ALKEM LABS LTD
209535 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT 2018/05/18 MACLEODS PHARMS LTD
210346 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT 2019/02/11 STRIDES PHARMA
活性成分:TRIAMCINOLONE ACETONIDE 剂型/给药途径:CREAM;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
085692 003 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 FOUGERA PHARMS
086413 003 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription No No AT Approved Prior to Jan 1, 1982 PADAGIS US
088042 001 ANDA TRIDERM TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription No No AT 1984/03/19 CROWN LABS
089798 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription No No AT 1991/05/31 COSETTE
040039 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription No No AT 1997/11/26 TARO
040671 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription No No AT 2006/06/09 MICRO LABS
207117 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription No No AT 2016/08/05 GLENMARK PHARMS LTD
208763 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription No No AT 2017/02/01 CHARTWELL RX
208848 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription No No AT 2017/09/18 ENCUBE
207651 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription No No AT 2017/12/26 ALKEM LABS LTD
209535 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription No No AT 2018/05/18 MACLEODS PHARMS LTD
210346 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% Prescription No No AT 2019/02/11 STRIDES PHARMA
活性成分:TRIAMCINOLONE ACETONIDE 剂型/给药途径:CREAM;TOPICAL 规格:0.5% 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
085692 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.5% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 FOUGERA PHARMS
086413 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.5% Prescription No No AT Approved Prior to Jan 1, 1982 PADAGIS US
088042 003 ANDA TRIDERM TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.5% Prescription No No AT 2015/03/25 CROWN LABS
208763 003 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.5% Prescription No No AT 2017/02/01 CHARTWELL RX
207651 003 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.5% Prescription No No AT 2017/12/26 ALKEM LABS LTD
209535 003 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.5% Prescription No No AT 2018/05/18 MACLEODS PHARMS LTD
210346 003 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.5% Prescription No No AT 2019/02/11 STRIDES PHARMA
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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