药品注册申请号:050006
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER LABORATORIES 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 VIBRAMYCIN DOXYCYCLINE FOR SUSPENSION;ORAL EQ 25MG BASE/5ML Yes Yes AB 1967/12/06 Approved Prior to Jan 1, 1982 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
2018/12/03 SUPPL 91 Approval Labeling STANDARD
2017/07/26 SUPPL 89 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2016/12/21 SUPPL 88 Approval Labeling STANDARD
2016/03/31 SUPPL 87 Approval Labeling STANDARD
2014/09/12 SUPPL 86 Approval Labeling STANDARD
2013/09/04 SUPPL 85 Approval Labeling STANDARD
2013/04/29 SUPPL 84 Approval Labeling STANDARD
2011/05/11 SUPPL 82 Approval Labeling STANDARD
2008/02/06 SUPPL 79 Approval Labeling STANDARD
2004/03/12 SUPPL 76 Approval Labeling STANDARD
2002/06/18 SUPPL 74 Approval Labeling STANDARD
1992/12/15 SUPPL 73 Approval Efficacy
1992/05/11 SUPPL 7 Approval Labeling
1992/05/11 SUPPL 5 Approval Labeling
1991/08/23 SUPPL 4 Approval Labeling
1983/11/21 SUPPL 2 Approval Labeling
1983/03/29 SUPPL 1 Approval Labeling
1982/08/31 SUPPL 72 Approval Labeling
1981/10/20 SUPPL 70 Approval Manufacturing (CMC)
1981/10/19 SUPPL 71 Approval Manufacturing (CMC)
1980/09/17 SUPPL 69 Approval Manufacturing (CMC)
1980/09/16 SUPPL 68 Approval Manufacturing (CMC)
1980/08/12 SUPPL 67 Approval Labeling
1979/09/20 SUPPL 65 Approval Manufacturing (CMC)
1979/09/19 SUPPL 66 Approval Manufacturing (CMC)
1978/10/19 SUPPL 64 Approval Manufacturing (CMC)
1978/07/12 SUPPL 63 Approval Labeling
1978/07/12 SUPPL 62 Approval Labeling
1978/03/13 SUPPL 61 Approval Labeling
1977/09/21 SUPPL 59 Approval Manufacturing (CMC)
1977/09/20 SUPPL 60 Approval Labeling
1977/09/14 SUPPL 58 Approval Manufacturing (CMC)
1976/12/06 SUPPL 57 Approval Manufacturing (CMC)
1976/09/13 SUPPL 56 Approval Manufacturing (CMC)
1976/09/10 SUPPL 55 Approval Manufacturing (CMC)
1976/05/20 SUPPL 54 Approval Manufacturing (CMC)
1976/04/09 SUPPL 53 Approval Manufacturing (CMC)
1976/01/15 SUPPL 52 Approval Labeling
1975/12/01 SUPPL 51 Approval Manufacturing (CMC)
1975/09/16 SUPPL 48 Approval Manufacturing (CMC)
1975/09/03 SUPPL 50 Approval Manufacturing (CMC)
1975/09/03 SUPPL 49 Approval Manufacturing (CMC)
1975/04/18 SUPPL 47 Approval Labeling
1974/09/24 SUPPL 46 Approval Manufacturing (CMC)
1974/09/24 SUPPL 45 Approval Manufacturing (CMC)
1974/06/21 SUPPL 44 Approval Manufacturing (CMC)
1974/06/06 SUPPL 43 Approval Labeling
1974/04/16 SUPPL 42 Approval Labeling
1973/10/30 SUPPL 39 Approval Labeling
1973/10/30 SUPPL 38 Approval Labeling
1973/10/30 SUPPL 37 Approval Labeling
1973/10/30 SUPPL 36 Approval Labeling
1973/10/02 SUPPL 41 Approval Manufacturing (CMC)
1973/10/02 SUPPL 40 Approval Manufacturing (CMC)
1973/07/02 SUPPL 35 Approval Labeling
1973/03/16 SUPPL 34 Approval Labeling
1972/09/18 SUPPL 33 Approval Manufacturing (CMC)
1972/06/23 SUPPL 32 Approval Labeling
1972/06/09 SUPPL 31 Approval Labeling
1971/09/16 SUPPL 30 Approval Manufacturing (CMC)
1971/05/25 SUPPL 29 Approval Labeling
1971/03/12 SUPPL 28 Approval Labeling
1971/02/22 SUPPL 27 Approval Manufacturing (CMC)
1971/02/08 SUPPL 26 Approval Labeling
1970/10/14 SUPPL 24 Approval Manufacturing (CMC)
1970/10/09 SUPPL 25 Approval Manufacturing (CMC)
1970/04/01 SUPPL 23 Approval Manufacturing (CMC)
1970/03/12 SUPPL 22 Approval Manufacturing (CMC)
1970/03/12 SUPPL 21 Approval Manufacturing (CMC)
1969/11/19 SUPPL 20 Approval Labeling
1969/11/07 SUPPL 19 Approval Manufacturing (CMC)
1969/09/09 SUPPL 17 Approval Manufacturing (CMC)
1969/09/08 SUPPL 18 Approval Manufacturing (CMC)
1969/07/31 SUPPL 16 Approval Labeling
1969/06/12 SUPPL 15 Approval Manufacturing (CMC)
1969/02/11 SUPPL 14 Approval Manufacturing (CMC)
1969/02/11 SUPPL 13 Approval Labeling
1968/12/30 SUPPL 12 Approval Labeling
1968/12/18 SUPPL 11 Approval Manufacturing (CMC)
1968/06/19 SUPPL 9 Approval Manufacturing (CMC)
1968/06/13 SUPPL 10 Approval Labeling
1968/04/08 SUPPL 8 Approval Manufacturing (CMC)
1968/02/05 SUPPL 6 Approval Manufacturing (CMC)
1967/12/06 ORIG 1 Approval UNKNOWN
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:DOXYCYCLINE 剂型/给药途径:FOR SUSPENSION;ORAL 规格:EQ 25MG BASE/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
050006 001 NDA VIBRAMYCIN DOXYCYCLINE FOR SUSPENSION;ORAL EQ 25MG BASE/5ML Prescription Yes Yes AB Approved Prior to Jan 1, 1982 PFIZER
065454 001 ANDA DOXYCYCLINE DOXYCYCLINE FOR SUSPENSION;ORAL EQ 25MG BASE/5ML Prescription No No AB 2008/07/16 CHARTWELL LIFE SCI
201678 001 ANDA DOXYCYCLINE DOXYCYCLINE FOR SUSPENSION;ORAL EQ 25MG BASE/5ML Prescription No No AB 2013/03/18 LUPIN LTD
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