药品注册申请号:017010
申请类型:NDA (新药申请)
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 DESONIDE DESONIDE CREAM;TOPICAL 0.05% Yes Yes AB 1972/01/04 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
2016/11/02 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
2014/05/15 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
2000/08/31 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
2000/03/17 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1996/09/09 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1995/06/12 SUPPL-14(补充) Approval Labeling STANDARD
1991/03/08 SUPPL-13(补充) Approval Labeling
1983/01/05 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1982/12/06 SUPPL-9(补充) Approval Labeling
1982/09/16 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1980/12/16 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1980/05/01 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1979/04/19 SUPPL-6(补充) Approval Labeling
1979/04/17 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1976/02/12 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1974/04/10 SUPPL-2(补充) Approval Supplement STANDARD
1972/01/04 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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
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:DESONIDE 剂型/给药途径:CREAM;TOPICAL 规格:0.05% 治疗等效代码:AB
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
017010 001 NDA DESONIDE DESONIDE CREAM;TOPICAL 0.05% Prescription Yes Yes AB Approved Prior to Jan 1, 1982 PADAGIS US
019048 001 NDA DESOWEN DESONIDE CREAM;TOPICAL 0.05% Prescription No No AB 1984/12/14 GALDERMA LABS LP
073548 001 ANDA DESONIDE DESONIDE CREAM;TOPICAL 0.05% Prescription No No AB 1992/06/30 TARO
074027 001 ANDA DESONIDE DESONIDE CREAM;TOPICAL 0.05% Prescription No No AB 1992/09/28 COSETTE
209729 001 ANDA DESONIDE DESONIDE CREAM;TOPICAL 0.05% Prescription No No AB 2017/07/24 GLENMARK SPECLT
210198 001 ANDA DESONIDE DESONIDE CREAM;TOPICAL 0.05% Prescription No No AB 2019/11/20 CADILA
214396 001 ANDA DESONIDE DESONIDE CREAM;TOPICAL 0.05% Prescription No No AB 2022/12/08 ALEMBIC
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database