药品注册申请号:020090
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER CHEMICALS DIV 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 FLUCONAZOLE FOR SUSPENSION;ORAL 50MG/5ML Yes No AB 1993/12/23 1993/12/23 Prescription
002 DIFLUCAN FLUCONAZOLE FOR SUSPENSION;ORAL 200MG/5ML Yes Yes AB 1993/12/23 Prescription
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
2019/02/07 SUPPL 47 Approval Labeling STANDARD
2018/03/09 SUPPL 46 Approval Labeling STANDARD
2018/01/22 SUPPL 49 Approval Labeling STANDARD
2017/10/27 SUPPL 48 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2014/10/30 SUPPL 44 Approval Labeling STANDARD
2014/07/28 SUPPL 43 Approval Manufacturing (CMC)
2014/03/24 SUPPL 42 Approval Labeling STANDARD
2014/01/07 SUPPL 41 Approval Manufacturing (CMC)
2013/09/13 SUPPL 40 Approval Labeling STANDARD
2011/11/16 SUPPL 38 Approval Labeling STANDARD
2011/06/06 SUPPL 34 Approval Labeling UNKNOWN
2011/04/26 SUPPL 36 Approval Labeling UNKNOWN
2010/08/05 SUPPL 31 Approval Labeling UNKNOWN
2008/03/31 SUPPL 22 Approval Labeling STANDARD
2004/10/07 SUPPL 17 Approval Labeling STANDARD
2004/10/07 SUPPL 14 Approval Labeling STANDARD
2004/10/07 SUPPL 12 Approval Labeling STANDARD
2004/03/24 SUPPL 19 Approval Labeling STANDARD
2002/08/07 SUPPL 15 Approval Labeling STANDARD
2001/03/05 SUPPL 13 Approval Manufacturing (CMC)
1999/02/22 SUPPL 11 Approval Labeling STANDARD
1997/08/05 SUPPL 10 Approval Labeling STANDARD
1997/02/19 SUPPL 9 Approval Labeling STANDARD
1996/08/06 SUPPL 8 Approval Labeling STANDARD
1996/07/23 SUPPL 6 Approval Labeling STANDARD
1995/12/22 SUPPL 5 Approval Manufacturing (CMC)
1995/02/21 SUPPL 4 Approval Labeling STANDARD
1995/02/21 SUPPL 3 Approval Labeling STANDARD
1994/06/30 SUPPL 2 Approval Labeling STANDARD
1994/03/22 SUPPL 1 Approval Labeling STANDARD
1993/12/23 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)
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:FLUCONAZOLE 剂型/给药途径:FOR SUSPENSION;ORAL 规格:50MG/5ML 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
020090 001 NDA DIFLUCAN FLUCONAZOLE FOR SUSPENSION;ORAL 50MG/5ML Prescription Yes No AB 1993/12/23 PFIZER
079150 001 ANDA FLUCONAZOLE FLUCONAZOLE FOR SUSPENSION;ORAL 50MG/5ML Prescription No No AB 2009/09/18 AUROBINDO PHARMA LTD
活性成分:FLUCONAZOLE 剂型/给药途径:FOR SUSPENSION;ORAL 规格:200MG/5ML 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
020090 002 NDA DIFLUCAN FLUCONAZOLE FOR SUSPENSION;ORAL 200MG/5ML Prescription Yes Yes AB 1993/12/23 PFIZER
079150 002 ANDA FLUCONAZOLE FLUCONAZOLE FOR SUSPENSION;ORAL 200MG/5ML Prescription No No AB 2009/09/18 AUROBINDO PHARMA LTD
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