药品注册申请号:017994
申请类型:NDA (新药申请)
申请人:PHARMACIA AND UPJOHN
申请人全名:PHARMACIA AND UPJOHN CO
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 PSORCON E DIFLORASONE DIACETATE OINTMENT;TOPICAL 0.05% No No None 1978/03/01 Approved Prior to Jan 1, 1982 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2017/10/25 SUPPL 26 Approval Labeling STANDARD
2003/05/30 SUPPL 22 Approval Labeling STANDARD
1999/01/21 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1997/10/10 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1988/05/03 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1986/01/03 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1984/05/31 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1984/03/29 SUPPL 16 Approval Labeling
1983/11/04 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1982/08/20 SUPPL 14 Approval Labeling
1982/08/20 SUPPL 13 Approval Labeling
1981/06/25 SUPPL 11 Approval Labeling
1981/05/05 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1981/02/18 SUPPL 9 Approval Labeling
1981/01/16 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1979/12/17 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1979/07/16 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1979/07/16 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1979/07/16 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1979/05/22 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1979/01/10 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1978/11/07 SUPPL 2 Approval Labeling
1978/03/01 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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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
本品无治疗等效药品
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