药品注册申请号:019949
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER CENTRAL RESEARCH
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 TABLET;ORAL 50MG Yes No AB 1990/01/29 1990/01/29 Prescription
002 DIFLUCAN FLUCONAZOLE TABLET;ORAL 100MG Yes No AB 1990/01/29 Prescription
003 DIFLUCAN FLUCONAZOLE TABLET;ORAL 200MG Yes Yes AB 1990/01/29 Prescription
004 DIFLUCAN FLUCONAZOLE TABLET;ORAL 150MG Yes No AB 1994/06/30 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 65 Approval Labeling STANDARD
2018/03/09 SUPPL 64 Approval Labeling STANDARD
2018/01/22 SUPPL 68 Approval Labeling STANDARD
2017/10/27 SUPPL 67 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2016/06/06 SUPPL 63 Approval Manufacturing (CMC)
2016/05/02 SUPPL 62 Approval Manufacturing (CMC)
2015/05/29 SUPPL 61 Approval Manufacturing (CMC)
2014/10/30 SUPPL 60 Approval Labeling STANDARD
2014/07/28 SUPPL 59 Approval Manufacturing (CMC)
2014/03/24 SUPPL 58 Approval Labeling STANDARD
2013/09/13 SUPPL 57 Approval Labeling STANDARD
2011/11/16 SUPPL 55 Approval Labeling STANDARD
2011/06/06 SUPPL 51 Approval Labeling UNKNOWN
2011/04/26 SUPPL 52 Approval Labeling STANDARD
2010/08/05 SUPPL 48 Approval Labeling UNKNOWN
2008/03/31 SUPPL 41 Approval Labeling STANDARD
2004/10/07 SUPPL 35 Approval Labeling STANDARD
2004/10/07 SUPPL 32 Approval Labeling STANDARD
2004/10/07 SUPPL 30 Approval Labeling STANDARD
2004/03/24 SUPPL 37 Approval Labeling STANDARD
2002/08/07 SUPPL 33 Approval Labeling STANDARD
2001/03/05 SUPPL 31 Approval Manufacturing (CMC)
2000/03/01 SUPPL 29 Approval Manufacturing (CMC)
1999/09/27 SUPPL 28 Approval Manufacturing (CMC)
1999/02/22 SUPPL 27 Approval Labeling STANDARD
1998/02/18 SUPPL 26 Approval Manufacturing (CMC)
1997/08/05 SUPPL 25 Approval Labeling STANDARD
1997/05/02 SUPPL 23 Approval Manufacturing (CMC)
1997/02/19 SUPPL 24 Approval Labeling STANDARD
1996/08/06 SUPPL 22 Approval Labeling STANDARD
1996/07/23 SUPPL 19 Approval Labeling STANDARD
1995/12/22 SUPPL 16 Approval Manufacturing (CMC)
1995/09/11 SUPPL 18 Approval Manufacturing (CMC)
1995/09/11 SUPPL 17 Approval Manufacturing (CMC)
1995/05/24 SUPPL 14 Approval Manufacturing (CMC)
1994/11/23 SUPPL 12 Approval Efficacy PRIORITY
1994/06/30 SUPPL 15 Approval Labeling STANDARD
1993/12/30 SUPPL 3 Approval Efficacy
1993/10/13 SUPPL 8 Approval Labeling STANDARD
1993/10/13 SUPPL 6 Approval Labeling
1993/10/13 SUPPL 2 Approval Labeling
1993/06/14 SUPPL 7 Approval Manufacturing (CMC)
1992/08/20 SUPPL 1 Approval Manufacturing (CMC)
1990/01/29 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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:TABLET;ORAL 规格:50MG 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
019949 001 NDA DIFLUCAN FLUCONAZOLE TABLET;ORAL 50MG Prescription Yes No AB 1990/01/29 PFIZER
076077 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2004/07/29 IVAX SUB TEVA PHARMS
076507 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2004/07/29 TARO
076658 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2004/07/29 DR REDDYS LABS INC
076665 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2004/07/29 CHARTWELL
076957 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2005/09/28 UNIQUE PHARM LABS
077253 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2006/01/25 GLENMARK GENERICS
077731 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2008/10/07 AUROBINDO PHARMA
078423 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2011/03/07 ANI PHARMS INC
208963 001 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 50MG Prescription No No AB 2017/02/16 ZYDUS PHARMS
活性成分:FLUCONAZOLE 剂型/给药途径:TABLET;ORAL 规格:100MG 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
019949 002 NDA DIFLUCAN FLUCONAZOLE TABLET;ORAL 100MG Prescription Yes No AB 1990/01/29 PFIZER
076077 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2004/07/29 IVAX SUB TEVA PHARMS
076507 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2004/07/29 TARO
076658 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2004/07/29 DR REDDYS LABS INC
076665 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2004/07/29 CHARTWELL
076957 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2005/09/28 UNIQUE PHARM LABS
077253 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2006/01/25 GLENMARK GENERICS
077731 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2008/10/07 AUROBINDO PHARMA
078423 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2011/03/07 ANI PHARMS INC
208963 002 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 100MG Prescription No No AB 2017/02/16 ZYDUS PHARMS
活性成分:FLUCONAZOLE 剂型/给药途径:TABLET;ORAL 规格:200MG 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
019949 003 NDA DIFLUCAN FLUCONAZOLE TABLET;ORAL 200MG Prescription Yes Yes AB 1990/01/29 PFIZER
076077 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2004/07/29 IVAX SUB TEVA PHARMS
076507 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2004/07/29 TARO
076658 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2004/07/29 DR REDDYS LABS INC
076665 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2004/07/29 CHARTWELL
076957 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2005/09/28 UNIQUE PHARM LABS
077253 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2006/01/25 GLENMARK GENERICS
077731 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2008/10/07 AUROBINDO PHARMA
078423 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2011/03/07 ANI PHARMS INC
208963 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 200MG Prescription No No AB 2017/02/16 ZYDUS PHARMS
活性成分:FLUCONAZOLE 剂型/给药途径:TABLET;ORAL 规格:150MG 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
019949 004 NDA DIFLUCAN FLUCONAZOLE TABLET;ORAL 150MG Prescription Yes No AB 1994/06/30 PFIZER
076077 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2004/07/29 IVAX SUB TEVA PHARMS
076507 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2004/07/29 TARO
076658 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2004/07/29 DR REDDYS LABS INC
076665 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2004/07/29 CHARTWELL
077253 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2006/01/25 GLENMARK GENERICS
077731 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2008/10/07 AUROBINDO PHARMA
078423 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2011/03/07 ANI PHARMS INC
208963 003 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2017/02/16 ZYDUS PHARMS
076957 004 ANDA FLUCONAZOLE FLUCONAZOLE TABLET;ORAL 150MG Prescription No No AB 2017/02/27 UNIQUE PHARM LABS
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