药品注册申请号：085691
申请类型：ANDA (仿制药申请)
申请人：FOUGERA PHARMS
申请人全名：FOUGERA 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 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.025% No No AT 1978/03/09 Approved Prior to Jan 1, 1982 Prescription
002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.5% No No AT Approved Prior to Jan 1, 1982 Prescription
003 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.1% No No AT Approved Prior to Jan 1, 1982 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
2004/08/23 SUPPL-35（补充） Approval Labeling
1996/03/07 SUPPL-33（补充） Approval Manufacturing (CMC)
1994/12/30 SUPPL-32（补充） Approval Manufacturing (CMC)
1988/05/20 SUPPL-31（补充） Approval Manufacturing (CMC)
1988/05/20 SUPPL-27（补充） Approval Manufacturing (CMC)
1988/03/25 SUPPL-30（补充） Approval Labeling
1987/07/31 SUPPL-29（补充） Approval Manufacturing (CMC)
1986/09/25 SUPPL-26（补充） Approval Manufacturing (CMC)
1983/05/04 SUPPL-25（补充） Approval Manufacturing (CMC)
1983/05/04 SUPPL-24（补充） Approval Manufacturing (CMC)
1982/10/28 SUPPL-23（补充） Approval Manufacturing (CMC)
1982/07/27 SUPPL-19（补充） Approval Manufacturing (CMC)
1982/07/27 SUPPL-17（补充） Approval Manufacturing (CMC)
1982/07/27 SUPPL-16（补充） Approval Manufacturing (CMC)
1982/07/27 SUPPL-11（补充） Approval Manufacturing (CMC)
1982/07/27 SUPPL-10（补充） Approval Manufacturing (CMC)
1978/03/09 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
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:OINTMENT;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
085691 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.025% Prescription No No AT Approved Prior to Jan 1, 1982 FOUGERA PHARMS
087385 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.025% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 PADAGIS US
089795 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.025% Prescription No No AT 1988/12/23 COSETTE
209828 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.025% Prescription No No AT 2018/11/23 MACLEODS PHARMS LTD
活性成分:TRIAMCINOLONE ACETONIDE 剂型/给药途径:OINTMENT;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
085691 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.5% Prescription No No AT Approved Prior to Jan 1, 1982 FOUGERA PHARMS
087385 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.5% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 PADAGIS US
206379 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.5% Prescription No No AT 2016/07/22 GLENMARK PHARMS LTD
208590 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.5% Discontinued No No AT 2017/03/03 PAI HOLDINGS PHARM
208925 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.5% Discontinued No No AT 2017/10/06 COSETTE
209828 003 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.5% Prescription No No AT 2018/11/23 MACLEODS PHARMS LTD
活性成分:TRIAMCINOLONE ACETONIDE 剂型/给药途径:OINTMENT;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
085691 003 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.1% Prescription No No AT Approved Prior to Jan 1, 1982 FOUGERA PHARMS
087385 003 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.1% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 PADAGIS US
089796 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.1% Prescription No No AT 1988/12/23 COSETTE
040037 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.1% Prescription No No AT 1994/09/30 TARO
205373 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.1% Prescription No No AT 2016/05/13 ENCUBE
208320 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.1% Prescription No No AT 2017/08/22 GLENMARK SPECLT
207365 001 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.1% Prescription No No AT 2018/10/12 CHARTWELL RX
209828 002 ANDA TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL 0.1% Prescription No No AT 2018/11/23 MACLEODS PHARMS LTD
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
©2006-2024 DrugFuture->U.S. FDA Drugs Database