药品注册申请号:050442
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 HYCLATE INJECTABLE;INJECTION EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1972/09/05 Approved Prior to Jan 1, 1982 Discontinued
002 VIBRAMYCIN DOXYCYCLINE HYCLATE INJECTABLE;INJECTION EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
2017/07/26 SUPPL 20 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 19 Approval Labeling STANDARD
2016/03/31 SUPPL 18 Approval Labeling STANDARD
2014/09/24 SUPPL 17 Approval Labeling STANDARD
2013/09/11 SUPPL 16 Approval Labeling STANDARD
2002/06/18 SUPPL 15 Approval Labeling STANDARD
1992/05/11 SUPPL 6 Approval Labeling
1989/08/03 SUPPL 5 Approval Manufacturing (CMC)
1981/05/11 SUPPL 14 Approval Labeling
1978/03/07 SUPPL 12 Approval Labeling
1977/10/03 SUPPL 11 Approval Labeling
1977/09/21 SUPPL 10 Approval Efficacy
1976/09/03 SUPPL 9 Approval Efficacy
1972/12/11 SUPPL 7 Approval Efficacy
1972/09/05 ORIG 1 Approval UNKNOWN
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品治疗等效的药品
本品无治疗等效药品
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