药品注册申请号:050007
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DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1967/12/05 Approved Prior to Jan 1, 1982 Discontinued
002 VIBRAMYCIN DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 100MG BASE Yes Yes AB Approved Prior to Jan 1, 1982 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2019/12/20 SUPPL-34(补充) Approval Labeling STANDARD
2018/12/03 SUPPL-33(补充) Approval Labeling STANDARD
2017/07/26 SUPPL-32(补充) 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-31(补充) Approval Labeling STANDARD
2016/03/31 SUPPL-30(补充) Approval Labeling STANDARD
2015/05/05 SUPPL-29(补充) Approval Manufacturing (CMC)
2014/10/28 SUPPL-28(补充) Approval Manufacturing (CMC)
2014/09/12 SUPPL-27(补充) Approval Labeling STANDARD
2013/09/04 SUPPL-26(补充) Approval Labeling STANDARD
2013/04/29 SUPPL-25(补充) Approval Labeling STANDARD
2011/05/11 SUPPL-23(补充) Approval Labeling STANDARD
2008/02/06 SUPPL-20(补充) Approval Labeling STANDARD
2004/03/12 SUPPL-16(补充) Approval Labeling STANDARD
2002/06/18 SUPPL-14(补充) Approval Labeling STANDARD
2002/05/15 SUPPL-15(补充) Approval Manufacturing (CMC)
2000/03/02 SUPPL-13(补充) Approval Manufacturing (CMC)
1992/12/15 SUPPL-12(补充) Approval Efficacy
1992/05/11 SUPPL-11(补充) Approval Labeling
1992/05/11 SUPPL-10(补充) Approval Labeling
1991/08/23 SUPPL-8(补充) Approval Labeling
1991/07/24 SUPPL-9(补充) Approval Manufacturing (CMC)
1967/12/05 ORIG-1(原始申请) 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 HYCLATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 100MG BASE 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
050007 002 NDA VIBRAMYCIN DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 100MG BASE Prescription Yes Yes AB Approved Prior to Jan 1, 1982 PFIZER
062031 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB Approved Prior to Jan 1, 1982 ACTAVIS LABS FL INC
062396 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 1984/05/07 HIKMA INTL PHARMS
062500 002 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 1984/09/11 CHARTWELL
062676 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 1986/07/10 SUN PHARM INDUSTRIES
207289 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2016/06/27 AMNEAL PHARMS
207774 002 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2018/05/31 ZYDUS LIFESCIENCES
210527 002 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2018/06/13 ALEMBIC
209402 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2019/10/07 CHANGZHOU PHARM
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