药品注册申请号:062505
申请类型:ANDA (仿制药申请)
申请人:CHARTWELL LIFE SCI
申请人全名:CHARTWELL LIFE SCIENCE LLC
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 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE No No AB 1984/09/11 1984/09/11 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
2014/12/02 SUPPL 70 Approval Labeling STANDARD
2012/04/25 SUPPL 68 Approval Labeling
2008/06/30 SUPPL 59 Approval Labeling
2006/03/28 SUPPL 56 Approval Labeling
2005/04/26 SUPPL 39 Approval Labeling
2004/07/27 SUPPL 37 Approval Labeling
2002/12/09 SUPPL 34 Approval Manufacturing (CMC)
2002/04/11 SUPPL 33 Approval Labeling
2002/03/20 SUPPL 31 Approval Manufacturing (CMC)
2002/03/20 SUPPL 30 Approval Manufacturing (CMC)
2002/03/20 SUPPL 29 Approval Manufacturing (CMC)
2001/12/21 SUPPL 32 Approval Manufacturing (CMC)
2001/09/12 SUPPL 27 Approval Manufacturing (CMC)
2000/07/26 SUPPL 26 Approval Labeling
2000/07/26 SUPPL 25 Approval Manufacturing (CMC)
2000/01/28 SUPPL 24 Approval Manufacturing (CMC)
1999/08/20 SUPPL 23 Approval Manufacturing (CMC)
1999/07/08 SUPPL 22 Approval Manufacturing (CMC)
1999/07/08 SUPPL 21 Approval Manufacturing (CMC)
1999/07/08 SUPPL 20 Approval Manufacturing (CMC)
1999/07/08 SUPPL 19 Approval Manufacturing (CMC)
1999/07/08 SUPPL 18 Approval Manufacturing (CMC)
1998/12/09 SUPPL 17 Approval Manufacturing (CMC)
1998/09/04 SUPPL 16 Approval Manufacturing (CMC)
1997/12/22 SUPPL 15 Approval Manufacturing (CMC)
1997/05/30 SUPPL 14 Approval Manufacturing (CMC)
1995/09/27 SUPPL 13 Approval Manufacturing (CMC)
1994/01/13 SUPPL 12 Approval Labeling
1993/06/09 SUPPL 11 Approval Labeling
1992/11/06 SUPPL 10 Approval Labeling
1992/09/03 SUPPL 9 Approval Manufacturing (CMC)
1992/09/03 SUPPL 8 Approval Manufacturing (CMC)
1992/05/01 SUPPL 7 Approval Labeling
1984/09/11 ORIG 1 Approval
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:TABLET;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
062269 002 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE Prescription No Yes AB 1982/11/08 CARIBE HOLDINGS
062421 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 1983/02/02 ACTAVIS LABS FL INC
062432 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 1983/02/15 MYLAN
062505 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 1984/09/11 CHARTWELL LIFE SCI
062677 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 1986/07/10 SUN PHARM INDUSTRIES
065095 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2003/07/02 HIKMA INTL PHARMS
207558 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2017/09/06 NOVEL LABS INC
207773 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2017/10/30 CADILA
209969 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2018/11/09 EMCURE PHARMS LTD
211343 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2019/10/09 CHANGZHOU PHARM
210536 001 ANDA DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2020/05/14 ALEMBIC PHARMS LTD
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