药品注册申请号:050480
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 CALCIUM SUSPENSION;ORAL EQ 50MG BASE/5ML Yes Yes None 1974/09/23 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 57 Approval Labeling STANDARD
2017/07/26 SUPPL 56 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 55 Approval Labeling STANDARD
2016/03/31 SUPPL 54 Approval Labeling STANDARD
2014/09/12 SUPPL 52 Approval Labeling STANDARD
2013/09/04 SUPPL 51 Approval Labeling STANDARD
2013/04/29 SUPPL 50 Approval Labeling STANDARD
2011/05/11 SUPPL 47 Approval Labeling STANDARD
2008/02/06 SUPPL 42 Approval Labeling STANDARD
2004/03/12 SUPPL 37 Approval Labeling STANDARD
2002/06/18 SUPPL 35 Approval Labeling STANDARD
2002/03/01 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1992/12/15 SUPPL 34 Approval Efficacy
1992/05/11 SUPPL 6 Approval Labeling
1992/05/11 SUPPL 5 Approval Labeling
1991/08/23 SUPPL 4 Approval Labeling
1983/03/29 SUPPL 1 Approval Labeling
1982/08/31 SUPPL 33 Approval Labeling
1981/09/30 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1981/09/29 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1981/04/21 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1980/09/30 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1980/08/12 SUPPL 28 Approval Labeling
1979/10/02 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1979/01/10 SUPPL 26 Approval Labeling
1978/11/14 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1978/09/25 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1978/08/01 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1978/07/24 SUPPL 22 Approval Labeling
1978/07/12 SUPPL 21 Approval Labeling
1978/03/13 SUPPL 20 Approval Labeling
1977/11/23 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1977/09/30 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1977/09/23 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1976/09/28 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1976/09/27 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1976/05/26 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1976/03/26 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1975/11/26 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1975/10/21 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1975/09/30 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1975/06/30 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1975/04/08 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1975/02/25 SUPPL 7 Approval Labeling
1975/01/06 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1974/09/23 ORIG 1 Approval Type 2 - New Active Ingredient 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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