药品注册申请号:019950
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER 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 DIFLUCAN IN SODIUM CHLORIDE 0.9% FLUCONAZOLE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) Yes No None 1990/01/29 1990/01/29 Discontinued
002 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) Yes No None 1990/01/29 Discontinued
003 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) Yes No None 1992/09/29 Discontinued
004 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE INJECTABLE;INJECTION 400MG/200ML (2MG/ML) Yes No None 1990/01/29 Discontinued
005 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE INJECTABLE;INJECTION 400MG/200ML (2MG/ML) Yes No None 1994/07/08 Discontinued
006 DIFLUCAN IN SODIUM CHLORIDE 0.9% FLUCONAZOLE INJECTABLE;INJECTION 400MG/200ML (2MG/ML) Yes No None 1990/01/29 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
2015/06/01 SUPPL 65 Approval Manufacturing (CMC)
2014/07/28 SUPPL 63 Approval Manufacturing (CMC)
2014/03/24 SUPPL 62 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2013/09/13 SUPPL 61 Approval Labeling STANDARD
2011/11/16 SUPPL 59 Approval Labeling STANDARD
2011/06/06 SUPPL 56 Approval Labeling UNKNOWN
2011/04/26 SUPPL 57 Approval Labeling UNKNOWN
2010/08/05 SUPPL 53 Approval Labeling UNKNOWN
2008/03/31 SUPPL 43 Approval Labeling STANDARD
2004/10/07 SUPPL 37 Approval Labeling STANDARD
2004/10/07 SUPPL 33 Approval Labeling STANDARD
2004/10/07 SUPPL 31 Approval Labeling STANDARD
2004/03/24 SUPPL 39 Approval Labeling STANDARD
2002/08/07 SUPPL 34 Approval Labeling STANDARD
2001/03/05 SUPPL 32 Approval Manufacturing (CMC)
1999/09/29 SUPPL 30 Approval Manufacturing (CMC)
1999/09/29 SUPPL 29 Approval Manufacturing (CMC)
1999/02/22 SUPPL 28 Approval Labeling STANDARD
1998/02/13 SUPPL 27 Approval Manufacturing (CMC)
1997/08/05 SUPPL 26 Approval Labeling STANDARD
1997/02/19 SUPPL 25 Approval Labeling STANDARD
1996/08/06 SUPPL 24 Approval Labeling STANDARD
1996/07/23 SUPPL 22 Approval Labeling STANDARD
1995/12/22 SUPPL 21 Approval Manufacturing (CMC)
1995/03/20 SUPPL 20 Approval Manufacturing (CMC)
1995/03/09 SUPPL 19 Approval Manufacturing (CMC)
1994/11/23 SUPPL 16 Approval Efficacy STANDARD
1994/08/22 SUPPL 17 Approval Manufacturing (CMC)
1994/07/08 SUPPL 12 Approval Manufacturing (CMC)
1994/06/30 SUPPL 18 Approval Labeling STANDARD
1993/12/30 SUPPL 4 Approval Efficacy
1993/10/13 SUPPL 10 Approval Labeling STANDARD
1993/10/13 SUPPL 7 Approval Labeling
1993/10/13 SUPPL 3 Approval Labeling
1993/06/22 SUPPL 11 Approval Manufacturing (CMC)
1993/06/14 SUPPL 8 Approval Manufacturing (CMC)
1993/02/10 SUPPL 9 Approval Manufacturing (CMC)
1992/09/29 SUPPL 2 Approval Manufacturing (CMC)
1990/01/29 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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