药品注册申请号:085025
申请类型:ANDA (仿制药申请)
申请人:PADAGIS US
申请人全名:PADAGIS US 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 HYDROCORTISONE HYDROCORTISONE CREAM;TOPICAL 2.5% No No AT 1983/04/21 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
1999/12/27 SUPPL-18(补充) Approval Manufacturing (CMC)
1996/05/08 SUPPL-17(补充) Approval Labeling
1996/05/08 SUPPL-16(补充) Approval Manufacturing (CMC)
1986/06/11 SUPPL-13(补充) Approval Manufacturing (CMC)
1983/04/21 ORIG-1(原始申请) Approval
1982/06/30 SUPPL-8(补充) Approval Manufacturing (CMC)
1982/06/02 SUPPL-9(补充) Approval Manufacturing (CMC)
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:HYDROCORTISONE 剂型/给药途径:CREAM;TOPICAL 规格:2.5% 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
085025 001 ANDA HYDROCORTISONE HYDROCORTISONE CREAM;TOPICAL 2.5% Prescription No No AT Approved Prior to Jan 1, 1982 PADAGIS US
088250 001 ANDA ANUSOL HC HYDROCORTISONE CREAM;TOPICAL 2.5% Prescription No No AT 1984/06/06 SALIX PHARMS
088799 001 ANDA HYDROCORTISONE HYDROCORTISONE CREAM;TOPICAL 2.5% Prescription No No AT 1984/11/09 TARO
089414 001 ANDA HYDROCORTISONE HYDROCORTISONE CREAM;TOPICAL 2.5% Prescription No Yes AT 1986/12/16 FOUGERA PHARMS INC
089682 001 ANDA HYDROCORTISONE HYDROCORTISONE CREAM;TOPICAL 2.5% Prescription No No AT 1988/03/10 ACTAVIS MID ATLANTIC
040503 001 ANDA HYDROCORTISONE HYDROCORTISONE CREAM;TOPICAL 2.5% Discontinued No No AT 2004/03/12 CHARTWELL MOLECULAR
040879 001 ANDA HYDROCORTISONE HYDROCORTISONE CREAM;TOPICAL 2.5% Prescription No No AT 2010/08/20 RISING
080706 007 ANDA ALA-CORT HYDROCORTISONE CREAM;TOPICAL 2.5% Prescription No No AT 2016/01/05 CROWN LABS
更多信息
药品NDC数据与药品包装、标签说明书
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